Class: First Generation Antihistamines
VA Class: AH104
CAS Number: 113-92-8
Brands: Advil Allergy Sinus, Ah-Chew, Alka-Seltzer Plus, Aller-Chlor, Allerest, Atrohist, Brexin L.A., Chlo-Amine, ChlorDex GP, Chlor-Mes D, Chlor-Phed, Chlor-Trimeton, Comhist, Comtrex, Coricidin, D.A. II, Dallergy, Deconamine, Dimetapp, Dristan, Dura-Vent, Efidac 24, EX-Histine, Extendryl, Flu-Relief, Histalet, Kolephrin, Kronofed-A, Mescolor, ND Clear, ND-Gesic, Novahistine, Omnihist LA, Phenyl Chlor Tan, Protid, Rescon, R-Tannate, Ryna, Rynatan, Rynatuss, Ry-Tuss, Sinarest, Sine-Off, Singlet, Sinutab, Sudafed, Tanafed, Tanoral, Teldrin, TheraFlu, Triaminic, Tri Hist , Triple-Tannate , Tussi-12, Tylenol Allergy Multi-Symptom, Tylenol Cold Multi-Symptom Children’s, Vanex Forte-R
Special Alerts:
[Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state “do not use” in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns. For more information visit the FDA website at: and .
Introduction
First generation antihistamine; a propylamine-derivative.a
Uses for Chlorpheniramine Maleate/Tannate, Dexchlorpheniramine Maleate
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Allergic Rhinitis
Symptomatic relief of allergic symptoms (e.g., rhinorrhea, sneezing, oronasopharyngeal irritation or itching, lacrimation, red, irritated, or itching eyes) caused by histamine release.100 149 168 169 170 487 494 509
Used in fixed combination with other agents (e.g., acetaminophen, dextromethorphan, guaifenesin, ibuprofen, methscopolamine, phenylephrine, pseudoephedrine) for relief of rhinorrhea, sneezing, lacrimation, itching eyes, oronasopharyngeal itching, and/or other symptoms (e.g., nasal/sinus congestion, cough) associated with seasonal or perennial allergic rhinitis and nonallergic (vasomotor) rhinitis.e f g h i j k l m n o p q r s t u
Use fixed-combination preparations only when symptoms amenable to each ingredient are present concurrently.
Chlorpheniramine Maleate/Tannate, Dexchlorpheniramine Maleate Dosage and Administration
Administration
Oral Administration
Administer orally.a
May be administered as self-medication in adults and children >2 years of age.a
Administer to children ≤2 years of age only under direction of a clinician.a Administer extended-release tablets to children 2 to ≤6 years of age under the direction of a clinician.a
May split certain commercially available extended-release tablets preparations (e.g., Extendryl) in half; however, do not crush or chew the tablets.i o p Consult manufacturer’s product labeling for appropriate administration of the specific preparation.
Take extended-release core tablets with fluid and swallow whole; do not divide, crush, chew, or dissolve.a Matrix core of the tablets does not completely dissolve and may be passed in the stool.a
Extended-release core tablets should not be used in children <12 years of age.a
Dosage
Individualize dosage according to patient’s response and tolerance.a
Fixed-combination preparations do not permit individual titration of dosages. When used in fixed combination with other agents (e.g., acetaminophen, dextromethorphan, guaifenesin, ibuprofen, methscopolamine, phenylephrine, pseudoephedrine), select a dosage that is within the usual therapeutic range for each ingredient. Lower maximum daily chlorpheniramine dosages may be necessary because of other ingredients included in the formulations.a Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.
Pediatric Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Allergic Rhinitis
Oral
Children 2 to <6 years of age: 1 mg every 4–6 hours (as conventional formulations).
Children 6 to <12 years of age: 2 mg every 4–6 hours (as conventional formulations) or 8 mg (as extended-release tablets) once daily at bedtime or during the day, as indicated.a
Children ≥12 years of age: 4 mg every 4–6 hours (as conventional formulations) or 8 or 12 mg (as extended-release tablets) twice daily in the morning and eveninga or 16 mg (as extended-release core tablet) once daily.a
Adults
Allergic Rhinitis
Oral
4 mg every 4–6 hours (as conventional formulations) or 8 or 12 mg (as extended-release tablets) twice daily in the morning and eveninga or 16 mg (as extended-release core tablets) once daily.a
Prescribing Limits
Pediatric Patients
Allergic Rhinitis
Oral
Children 2 to <6 years of age: Maximum 6 mg daily (as conventional formulations).
Children 6 to <12 years of age: Maximum 12 mg daily (as conventional formulations) or maximum 8 mg daily (as extended-release tablets).a
Children ≥12 years of age: Maximum 24 mg daily (as immediate-release formulations or extended-release tablets)a or maximum 16 mg daily (as extended-release core tablet).a
Adults
Allergic Rhinitis
Oral
Maximum 24 mg daily (as conventional formulations or extended-release tablets)a or maximum 16 mg daily (extended-release core tablets).a
Cautions for Chlorpheniramine Maleate/Tannate, Dexchlorpheniramine Maleate
Warnings/Precautions
Sensitivity Reactions
Tartrazine Sensitivity
Some commercially available preparations may contain the dye tartrazine (FD&C yellow No. 5); possible allergic reactions in susceptible individuals (e.g., those sensitive to aspirin).
General Precautions
CNS Effects
Possible CNS depression (e.g., drowsiness, dizziness, weakness).b
Caution when driving a motor vehicle or operating machinery.c (See CNS Depressants under Interactions.)
Anticholinergic Effects
Possible anticholinergic effects (e.g., dryness of mouth, nose, and throat; dysuria; urinary retention).b Use with caution, if at all, in patients with angle-closure glaucoma, prostatic hypertrophy,c stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction.b
Bronchopulmonary Effects
Possible bronchopulmonary effects (e.g., tightness of the chest, thickening of bronchial secretions, wheezing).b Use not recommended, unless under the direction of a clinician, in patients who have a breathing problem (e.g., emphysema, chronic bronchitis).467 485 486 c Use generally not recommended in asthmatics who previously experienced a serious antihistamine-induced adverse bronchopulmonary effect.467 481
GI Obstruction
Possible GI obstruction with administration of extended-release core tablets in patients with severe narrowing of the esophagus, stomach, or intestine.a
Phenylketonuria
Some commercially available preparations may contain aspartame (NutraSweet) which is metabolized in the GI tract to phenylalanine.
Use of Fixed Combinations
When used in fixed combination with other agents (e.g., acetaminophen, dextromethorphan, guaifenesin, ibuprofen, methscopolamine, phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).d e f g h i j k l m n o p q r s t u
Specific Populations
Pregnancy
Category B. Use not recommended during the third trimester.a
Lactation
Not known whether chlorpheniramine is distributed into milk; discontinue nursing or chlorpheniramine because of potential risk to nursing infants.a
Pediatric Use
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Possible severe reactions (e.g., seizures) in neonates; use not recommended in premature or full-term neonates.a Possible paradoxical excitement (e.g., restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures).b
Use conventional and extended-release preparations only under the direction and supervision of a clinician in children <6 years of age and in those <12 years of age, respectively.a Safety and efficacy of extended-release core tablets in children <12 years of age not established.a
Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Use such preparations in children <2 years of age with caution and only as directed by clinician. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.
Geriatric Use
Possible increased risk of dizziness, sedation, and hypotension.b
Common Adverse Effects
Sedation (e.g., drowsiness, dizziness, weakness), CNS stimulation (e.g., restlessness, insomnia, nervousness).a c
Interactions for Chlorpheniramine Maleate/Tannate, Dexchlorpheniramine Maleate
CNS Depressants
Potential pharmacologic interaction (additive CNS depression) with alcohol and other CNS depressants (e.g., hypnotics, sedatives, tranquilizers).b
Laboratory Test Interferences
Antihistamines may suppress inhalation-challenge testing with histamine or antigen as well as the wheal and flare reactions to antigen skin testing.
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
MAO inhibitors | MAO inhibitors prolong and intensify anticholinergic effects of antihistaminesb |
Chlorpheniramine Maleate/Tannate, Dexchlorpheniramine Maleate Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration, but only 25–45% (conventional tablets) or 35–60% (solution) of a single oral dose reaches the systemic circulation as unchanged drug.
Bioavailability of extended-release preparations is reduced compared to conventional tablets or solution.
Peak plasma concentrations generally occur within 2–6 hours following oral administration of conventional tablets or solution.
Onset
Antihistamine effect is apparent within 6 hours after a single dose.
Duration
Antihistamine effect may persist for ≥24 hours.
Distribution
Extent
Undergoes rapid and extensive distribution; however, distribution has not been characterized fully.
Plasma Protein Binding
Approximately 69–72%.
Elimination
Metabolism
Undergoes substantial metabolism in the GI mucosa during absorption and on first pass through the liver. Rapidly and extensively metabolized principally to at least 2 unidentified metabolites and monodesmethylchlorpheniramine and didesmethylchlorpheniramine.
Elimination Route
Excreted in urine.
Half-life
Terminal elimination half-life of chlorpheniramine is about 12–43 hours.
Special Populations
Terminal elimination half-life in children is about 9.6–13.1 hours (range: 5.2–23.1 hours).
Terminal elimination half-life in patients with chronic renal failure undergoing hemodialysis is about 280–330 hours.
Stability
Storage
Oral
Tablets, Chewable Tablets, and Extended-release Capsules
Tight containers at 15–30°C.a
Extended-release Tablets
Well-closed containers at 15–30°C.a
Extended-release Core Tablets
4–30°C in a dry place.a
Oral Solution
Tight, light-resistant containers at 15–30°C; avoid freezing.a
Actions and SpectrumActions
Blocks H1-receptor sites and prevents the action of histamine on the cell.b
Suppresses flare and pruritus that accompany the endogenous release of histamine.b
Exhibits some activities common to anticholinergics, ganglionic and adrenergic blocking agents, local anesthetics, and antispasmodics.b
Causes less drowsiness and more CNS stimulation than some other first generation antihistamines.b
Antihistamines do not block the stimulating effect of histamine on gastric acid secretion, which is mediated by H2-receptors of the parietal cells.b
Advice to Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of informing individuals who perform potentially hazardous tasks requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle) about possible drowsiness, dizziness, or weakness.c
Importance of avoiding alcoholic beverages during antihistamine therapy.350 407 585 586
Importance of contacting a clinician if abdominal pain or vomiting develops during therapy with extended-release core tablets.a
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.a Importance of patients already receiving another CNS depressant (e.g., sedatives, tranquilizers) not undertaking self-medication without first consulting a clinician.350 407 585 586
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
In response to concerns regarding the safety and efficacy of cough/cold preparations in young children, many OTC cough/cold preparations specifically formulated for infants have been voluntarily withdrawn from the US market. Therefore, some of the preparations described below may no longer be commercially available in the US.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Bulk | Powder* | |||
Oral | Capsules, extended-release | 8 mg* | ||
12 mg* | Teldrin Allergy (with benzyl alcohol) | Hogil | ||
Solution | 2 mg/5 mL* | Aller-Chlor Syrup (with alcohol 7%) | Rugby | |
Chlor-Trimeton Allergy Syrup (with alcohol 7% parabens and propylene glycol) | Schering-Plough | |||
Tablets | 4 mg* | Aller-Chlor | Rugby | |
Chlor-Trimeton 4 Hour Allergy (scored) | Schering-Plough | |||
Tablets, chewable | 2 mg | Chlo-Amine | Bayer | |
Tablets, extended-release | 8 mg* | Chlor-Trimeton 8 Hour Allergy (with butylparaben) | Schering-Plough | |
12 mg* | Chlor-Trimeton 12 Hour Allergy (with butylparaben) | Schering-Plough | ||
Tablets, extended-release core | 16 mg (core 12 mg with 4 mg immediate release) | Efidac 24 Chlorpheniramine (with povidone) | Hogil |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules, extended-release | 4 mg with Pseudoephedrine Hydrochloride 60 mg | Atrohist Pediatric (with propylene glycol) | Celltech |
Kronofed-A-Jr. Kronocaps | Ferndale | |||
Rescon JR | Ion | |||
8 mg with Methscopolamine Nitrate 2.5 mg and Phenylephrine Hydrochloride 20 mg | Vanex Forte-R | Jones Pharma | ||
8 mg with Pseudoephedrine Hydrochloride 120 mg | Brexin L.A. (with benzyl alcohol and parabens) | Savage | ||
Chlor-Phed Timecelles | Shire | |||
Chlorpheniramine Maleate with Pseudoephedrine Hydrochloride Capsules | Eon, Sandoz | |||
Deconamine SR (with parabens) | Kenwood | |||
Kronofed-A Kronocaps | Ferndale | |||
ND Clear | Seatrace | |||
Rescon-ED | Ion | |||
12 mg with Pseudoephedrine Hydrochloride 120 mg | Rescon | Ion | ||
Capsules, liquid-filled | 2 mg with Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, and Phenylephrine Hydrochloride 5 mg | Alka-Seltzer Plus Cold Medicine (with povidone and propylene glycol) | Bayer | |
Solution | 1 mg/1 mL with Phenylephrine Hydrochloride 3.5 mg/1 mL and Dextromethorphan Hydrobromide 3mg/1 mL | Sildec-PE-DM Drops | Silarx | |
CPM/PE/DM Pediatric Drops (sugar-free, alcohol-free) | Cypress | |||
1 mg/5 mL with Acetaminophen 160 mg/5 mL and Dextromethorphan Hydrobromide 7.5 mg/5 mL | Triaminic Flu, Cough & Fever Syrup | Novartis | ||
1 mg/5 mL with Acetaminophen 160 mg/5 mL, Dextromethorphan 5 mg/ 5 mL, and Phenylephrine Hydrochloride 2.5 mg/5 mL | Children’s Tylenol Plus Multi-Symptom Cold | McNeil | ||
1 mg/5 mL with Dextromethorphan Hydrobromide 7.5 mg/5 mL | Dimetapp Long Acting Cough Plus Cold (with propylene glycol) | Wyeth | ||
1 mg/5 mL with Methscopolamine Nitrate 1.25 mg/5 mL and Phenylephrine Hydrochloride 10 mg/5 mL | Extendryl Syrup (with propylene glycol) | Auriga | ||
2 mg/5 mL with Methscopolamine Nitrate 0.625 mg/5 mL and Phenylephrine Hydrochloride 10 mg/5 mL | Dallergy Syrup | Laser | ||
2 mg/5 mL with Methscopolamine Nitrate 0.625 mg/5 mL and Phenylephrine Hydrochloride 10 mg/5 mL | Chlor-Mes D | Cypress | ||
2 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL | Novahistine Elixir (with alcohol 5%) | Alpharma | ||
2 mg/5 mL with Phenylephrine Hydrochloride 10 mg/5 mL, Guaifenesin 100mg/5 mL and Dextromethorphan Hydrochloride 7.5 mg/5 mL | ChlorDex GP Syrup (with propylene glycol) | Cypress | ||
2 mg/5 mL with Phenylephrine Hydrochloride 10 mg/5 mL and Methscopolamine nitrate 0.625 mg/5 mL | Chlor-Mes D Syrup (sugar-free, alcohol-free) | Cypress | ||
3 mg/5 mL with Pseudoephedrine Hydrochloride 45 mg/5 mL | Histalet Syrup | Numark | ||
4 mg/5 mL with Phenylephrine Hydrochloride 12.5 mg/5 mL and Dextromethorphan Hydrobromide 15 mg/5 mL | Sildec-PE-DM Syrup | Silarx | ||
CPM/PE/DM Syrup (sugar-free, alcohol-free) | Cypress | |||
Tablets | 2 mg with Acetaminophen 300 mg, Phenylephrine Hydrochloride 5 mg, and Pyrilamine Maleate 12.5 mg | ND-Gesic | Hyrex | |
2 mg with Acetaminophen 325 mg | Coricidin HBP Cold & Flu (with butylparaben and povidone) | Schering-Plough | ||
2 mg with Acetaminophen 325 mg and Phenylephrine Hydrochloride 5 mg | Tylenol Allergy Multi-Symptom Gelcaps (with benzyl alcohol and parabens) | McNeil | ||
Sinutab Sinus Tablets (with povidone) | Pfizer | |||
2 mg with Acetaminophen 325 mg, Phenylephrine Hydrochloride 5 mg, and Dextromethorphan Hydrobromide 15 mg | TheraFlu Nighttime Severe Cold Caplets (with povidone) | Novartis | ||
2 mg with Acetaminophen 500 mg and Phenylephrine Hydrochloride 5 mg | Sine-Off Sinus and Cold Caplets (with povidone and propylene glycol) | Hogil | ||
2 mg with Phenylephrine Hydrochloride 10 mg and Phenyltoloxamine Citrate 25 mg | Comhist (scored) | Lee Pharmaceuticals | ||
2 mg with Pseudoephedrine Hydrochloride 30 mg | Allerest Maximum Strength | Heritage | ||
4 mg with Acetaminophen 650 mg and Pseudoephedrine Hydrochloride 60 mg | Singlet Caplets | SmithKline Beecham Consumer | ||
4 mg with Dextromethorphan Hydrobromide 30 mg | Coricidin HBP Cough & Cold | Schering-Plough | ||
4 mg with Methscopolamine Nitrate 1.25 mg and Phenylephrine Hydrochloride 10 mg | Dallergy | Laser | ||
4 mg with Pseudoephedrine Hydrochloride 60 mg | Sudafed Cold & Allergy (with povidone; scored) | Pfizer | ||
4 mg with Pseudoephedrine Sulfate 60 mg | Chlor-Trimeton 4 Hour Allergy Decongestant (with povidone) | Schering-Plough | ||
Tablets, chewable | 1 mg with Dextromethorphan Hydrobromide 5 mg | Triaminic Cough & Runny Nose Softchews (with aspartame and povidone) | Novartis | |
2 mg with Methscopolamine Nitrate 1.25 mg and Phenylephrine Hydrochloride 10 mg | Ah-Chew | WE Pharmaceuticals | ||
Tablets, extended-release | 2 mg with Acetaminophen 325 mg and Phenylephrine Hydrochloride 5 mg | Tylenol Allergy Multi-Symptom Rapid Release Gelcaps (with benzyl alcohol, parabens, and propylene glycol) | McNeil | |
2 mg with Methscopolamine Nitrate 1.25 mg and Phenylephrine Hydrochloride 10 mg | Extendryl Chewable (with povidone) | Auriga | ||
4 mg with Methscopolamine Nitrate 1.25 mg and Phenylephrine Hydrochloride 10 mg | Extendryl Jr. (with povidone; scored) | Auriga | ||
8 mg with Acetaminophen 500 mg and Phenylephrine Hydrochloride 40 mg | Protid | Lunsco | ||
8 mg with Methscopolamine Nitrate 1.25 mg and Phenylephrine Hydrochloride 20 mg | CPM 8/PE 20/ MSC 1.25 Tablets (with povidone) | Cypress | ||
8 mg with Methscopolamine Nitrate 2.5 mg and Phenylephrine Hydrochloride 20 mg | Extendryl Sr. (with povidone; scored) | Auriga | ||
8 mg with Methscopolamine Nitrate 2.5 mg and Dextromethorphan 30 mg | Extendryl DM (scored) | Auriga | ||
8 mg with Pseudoephedrine Sulfate 120 mg | Chlor-Trimeton 12 Hour Allergy Decongestant (with butylparaben and povidone) | Schering-Plough | ||
Tablets, extended-release, film-coated | 8 mg with Methscopolamine Nitrate 2.5 mg and Pseudoephedrine Hydrochloride 120 mg | Mescolor (scored) | Horizon | |
Tablets, film-coated | 2 mg with Acetaminophen 325 mg and Phenylephrine Hydrochloride 5 mg | Dristan Cold (with povidone) | Wyeth | |
Tylenol Allergy Multi-Symptom Caplets | McNeil | |||
2 mg with Acetaminophen 325 mg and Pseudoephedrine Hydrochloride 30 mg | Flu-Relief Caplets | Pfeiffer | ||
Kolephrin Caplets | Pfeiffer | |||
2 mg with Ibuprofen 200 mg and Pseudoephedrine Hydrochloride 30 mg | Advil Allergy Sinus Caplets (with propylene glycol) | Wyeth |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Suspension | 2 mg/5 mL with Phenylephrine Tannate 5 mg/5 mL and Pyrilamine Tannate 12.5 mg/5 mL | Atrohist Pediatric (with methylparaben; dye-free) | Celltech |
Tanoral Pediatric | Econolab | |||
Tanoral-S Pediatric | Econolab | |||
Tri Hist Pediatric Suspension (with methylparaben) | Hi-Tech, | |||
Triple-Tannate Pediatric Suspension (with methylparaben) | Hi-Tech | |||
4.5 mg/5 mL with Phenylephrine Tannate 5 mg/5 mL | Phenyl Chlor Tan | Hi-Tech | ||
4.5 mg/5 mL with Pseudoephedrine Tannate 75 mg/5 mL | Tanafed | Horizon | ||
Tablets, chewable | 4.5 mg with Phenylephrine Tannate 5 mg | Rynatan (scored) | Med Pointe |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Solution | 1 mg/5 mL with Phenylephrine Hydrochloride 10 mg/5 mL, and Methscopolamine Nitrate 1.25 mg/5 mL | Extendryl Syrup (with propylene glycol) | Auriga |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Dallergy JR 4-20MG 12-hr Capsules (LASER PHARMACEUTICALS): 30/$83.54 or 90/$213.7
Donatussin 10-2-15-100MG/5ML Syrup (LASER PHARMACEUTICALS): 473/$36.25 or 1419/$108.75
R-Tanna 9-25MG Tablets (PRASCO LABORATORIES): 30/$39.99 or 90/$102.97
Rynatan 9-25MG Tablets (MEDA PHARMACEUTICALS): 30/$122.99 or 90/$349.97
Rynatan Pediatric 4.5-5MG/5ML Suspension (MEDA PHARMACEUTICALS): 120/$95.99 or 360/$269.99
Sudal 12 4-30MG Chewable Tablets (ATLEY PHARMACEUTICALS): 100/$109.99 or 300/$310.98
SudoGest Sinus/Allergy 4-60MG Tablets (MAJOR PHARMACEUTICALS): 24/$11.99 or 48/$12.98
Tannate Pediatric 4.5-5MG/5ML Suspension (AMNEAL PHARMACEUTICALS): 100/$25.99 or 300/$59.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
z. The following references were copied from the Antihistamines General Statement:
100. Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy, bronchodilator and antiasthmatic products. [21 CFR 341] Fed Regist. 1976; 41:38312-424. (Cited in previous revisions as reference #16.) (IDIS 66640)
148. Schering Corporation. Disophrol tablets patient information. Kenilworth, NJ. Undated.
149. Douglas WW. Histamine and 5-hydroxytryptamine (serotonin) and their antagonists. In: Gilman AG, Goodman LS, Rall TW et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan Publishing Company; 1985:605-38.
168. AMA Division of Drugs. AMA drug evaluations. 5th ed. Chicago: American Medical Association; 1983:1465-79.
169. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; tentative final monograph for OTC antihistamine drug products. [21 CFR Part 341] Fed Regist. 1985; 50:2200-18. (IDIS 195256)
170. Anon. Treatment of seasonal and perennial rhinitis. BMJ. 1981; 283:808-10. [PubMed 6117350]
350. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; tentative final monograph for OTC antihistamine drug products. [21 CFR Parts 201, 310, 341, 369] Fed Regist. 1987; 52:31892-914.
407. Food and Drug Administration. Nighttime sleep-aid products for over-the-counter human use; final monograph. [21 CFR Part 338] Fed Regist. 1989; 54:6814-27. (IDIS 250549)
467. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC antihistamine drug products. 21 CFR Parts 201, 310, 341, and 369. Final rule. [Docket No. 76N-052H] Fed Regist. 1992; 57:58356-76.
481. Meltzer EO. To use or not to use antihistamines in patients with asthma. Ann Allergy. 1990; 64(Part II):183-6. [IDIS 297019] [PubMed 1967918]
485. Food and Drug Administration. Antiemetic drug products for over-the-counter human use; proposed amendment to the monograph. 21 CFR Part 336. Notice of proposed rulemaking. [Docket No. 92N-0346] Fed Regist. 1993; 58:45216-7.
486. Food and Drug Administration. Sleep aids and antiemetics. From: FDA Bulletin Board. 1993 Aug 26.
487. Simons FER, Simons KJ. The pharmacology and use of H1-receptor-antagonist drugs. N Engl J Med. 1994; 330:1663-70. [IDIS 330632] [PubMed 7909915]
494. Burroughs Wellcome Co. Semprex-D (acrivastine and pseudoephedrine HCl) capsules. Research Triangle Park, NC; 1994 April.
509. Pfizer Laboratories. Zyrtec (cetirizine hydrochloride) tablets and syrup prescribing information. New York, NY; 1998 May.
585. Novartis. Tavist (clemastine fumarate) tablets prescribing information. In: Physicians’ desk reference for nonprescription drugs. 52nd edition. Montvale NJ: Medical Economics Company Inc; 1998:708-9.
586. Warner-Lambert. Actifed cold and allergy tablets prescribing information. In: Physicians’ desk reference for nonprescription drugs. 52nd edition. Montvale NJ: Medical Economics Company Inc; 1998:798.
693. Srinivasan A, Budnitz D, Shehab N et al. Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep. 2007; 56:1-4. [PubMed 17218934]
694. Food and Drug Administration. Cough and cold medications in children less than two years of age. MedWatch drug labeling changes. Rockville, MD; January 2007. From FDA website.
698. Anon. Makers pull cold medicines sold for infants. CNN News, 2007 Oct 11. From CNN.com website.
a. AHFS Drug Information 2008. McEvoy GK, ed. Chlorpheniramine. Bethesda, MD: American Society of Health-System Pharmacists; 2008:11–14.
b. AHFS Drug Information 2008. McEvoy GK, ed. Antihistamines General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1-8.
c. Schering Plough. Chlor-Trimeton tablets prescribing information. In: PDR for Nonprescription Drugs and Dietary Supplements. Montvale, NJ: Medical Economics Company In; 2003.
d. Schering-Plough Corporation. Coricidin HBP Cough & Cold (chlorpheniramine maleate and dextromethorphan hydrobromide) tablets patient information. From Schering-Plough website. Accessed 2008 Feb 19.
e. McNeil Consumer Healthcare. Tylenol Allergy Multi-symptom (acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride) gelcaps and caplets patient information. From McNeil Consumer website. Accessed 2008 Feb 18.
f. Wyeth Consumer Healthcare. Dimetapp Long Acting Cough Plus Cold (chlorpheniramine maleate and dextromethorphan hydrobromide) syrup patient information. From Wyeth Consumer Healthcare website. Accessed 2008 Feb 19.
g. Wyeth Consumer Healthcare. Advil Allergy Sinus (chlorpheniramine maleate, ibuprofen, and pseudoephedrine hydrochloride) caplets patient information. From Wyeth Consumer Healthcare website. Accessed 2008 Feb 19.
h. Novartis Consumer Health, Inc. Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide) syrup patient information. From Novartis Consumer Health website. Accessed 2008 Feb 19.
i. Cypress Pharmaceutical, Inc. CPM 8/PE 20/MSC 1.25 (chlorpheniramine maleate, phenylephrine hydrochloride, and methscopolamine nitrate) extended-release tablets prescribing information. Madison, MS; 2003 Dec.
j. Cypress Pharmaceutical, Inc. Chlor-Mes D (chlorpheniramine maleate, phenylephrine hydrochloride, and methscopolamine nitrate) syrup prescribing information. Madison, MS; 2006 Jan.
k. Silarx Pharmaceuticals, Inc. Chlorpheniramine/PhenylephrineDextromethorphan oral drops and syrup prescribing information. Spring Valley, NY; 2005 Nov.
l. Cypress Pharmaceutical, Inc. ChlorDex GP (dextromethorphan hydrobromide, chlorpheniramine maleate, phenylephrine hydrochloride, and guaifenesin) syrup prescribing information. Madison, MS; 2006 Oct.
m. Hogil Pharmaceutical Corporation. Sine-Off Sinus/Cold (acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride) patient information. From Hogil Pharmaceutical website. Accessed 2008 Feb 20.
n. Medpoint Pharmaceuticals. Rynatan (chlorpheniramine tannate and phenylephrine tannate) chewable pediatric tablets prescribing information. Somerset, NJ; 2006 Aug.
o. Auriga Pharmaceuticals, LLC. Extendryl DM (chlorpheniramine maleate, dextromethorphan, and methscopolamine nitrate) extended-release tablets prescribing information. Norcross, GA; 2005 Sep.
p. Auriga Pharmaceuticals, LLC. Extendryl JR (chlorpheniramine maleate, phenylephrine hydrochloride, and methscopolamine nitrate) tablets prescribing information. Norcross, GA; 2007 Mar.
q. Kenwood Therapeutics. Deconamine (chlorpheniramine maleate and d-pseudoephedrine hydrochloride) sustained-release capsules prescribing information. Fairfield, NJ; 2003 Oct.
r. Bayer Healthcare. Alka-Seltzer Plus Cough and Cold (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrochloride, and phenylephrine hydrochloride) capsules patient information. From Alka-Seltzer website. Accessed 2008 Feb 21.
s. Hi-Tech Pharmacal. Tri-Hist (chlorphenirmaine tannate, phenylephrine tannate, pyrilamine tannate) suspension prescribing information. Amityville, NY; 2005 Aug.
t. Hi-Tech Pharmacal. Phenyl Chlor-Tan (chlorphenirmaine tannate, phenylephrine tannate) pediatric suspension prescribing information. Amityville, NY; 2004 Oct.
u. Auriga Pharmaceuticals, LLC. Extendryl (phenylephrine hydrochloride, methscopolamine nitrate, and dexchlorpheniramine maleate) syrup prescribing information. Norcross, GA; 2006 Nov.
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