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AlleRx Dose Pack DF

Generic Name: chlorpheniramine maleate, methscopolamine nitrate
Dosage Form: tablets

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

AlleRx® DOSE PACK DF

AM Dose - 4 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate

PM Dose - 8 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate

AlleRx® DOSE PACK DF 30

AM Dose - 4 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate

PM Dose - 8 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate

DESCRIPTION

Each AM tablet contains: Each PM tablet contains:
Chlorpheniramine Maleate .....4 mg Chlorpheniramine Maleate .....8 mg
Methscopolamine Nitrate.......2.5 mg Methscopolamine Nitrate .......2.5 mg

Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine, gamma-(4 chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1).

Methscopolamine nitrate is an anticholinergic having the chemical name 3-oxa-9-azoniatricyclo [3.3.1.0 2 4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate, [7(S)-(1α, 2β, 4β, 5α, 7β)]; C17H21NO4•CH3NO3, MW = 80.4

Inactive Ingredients:

AM tablets: Each white AM tablet contains Hypromellose, Dicalcium Phosphate, Talc, Stearic Acid and Magnesium Stearate.

PM tablets: Each blue PM tablet contains Hypromellose, Dicalcium Phosphate, Talc, FD&C Blue #1 (aluminum lake) Dye, Stearic Acid and Magnesium Stearate.

CLINICAL PHARMACOLOGY

Chlorpheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses.

Methscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic scopolamine which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain barrier. Its antimuscarinic effect causes inhibition of salivary secretions, reduction in volume and total acid content of gastric secretion, and inhibition of gastrointestinal motility. It is poorly and unreliably absorbed. Drug effects appear in about one hour and persist for about 4 to 6 hours. It is excreted primarily in the urine and bile, or as unabsorbed drug in feces.

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INDICATIONS AND USAGE

For the temporary relief of symptoms associated with allergic rhinitis.

CONTRAINDICATIONS

This product is contraindicated in patients with hypersensitivity to methscopolamine nitrate and chlorpheniramine maleate. AlleRx® DF is contraindicated in patients with severe hypertension, severe coronary artery disease, and in nursing mothers. AlleRx is also contraindicated in patients with narrow-angle glaucoma, and peptic ulcer.

WARNINGS

Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed recommended dosage. Methscopolamine nitrate may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or performing hazardous work while taking AlleRx.

Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate the hypotension effects of nitrates. Co-administration of AlleRx DF and sildenafil citrate has not been studied. Therefore, the use of sildenafil citrate and AlleRx DF together is not recommended.

PRECAUTIONS

General: AlleRx should be used with caution in patients with diabetes mellitus, hypertension, and cardiovascular disease. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Methscopolamine nitrate should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, or ulcerative colitis.

Drug Interactions: Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy Category C: It is not known whether AlleRx can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AlleRx should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this combination drug is excreted in human milk.

Pediatric Use: The safety and effectiveness in children under 12 years of age have not been established.

Geriatric Use: The elderly (60 years and older) are more likely to experience adverse reactions to methscopolamine.

Adverse Reactions

Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, and increased irritability or excitement (especially in children). Antihistamines and anticholinergics may cause drowsiness, dizziness, blurred vision, and excessive dryness of the nose, throat, and mouth.

OVERDOSAGE AND TREATMENT OF OVERDOSAGE

The treatment of overdosage should provide symptomatic and supportive care. Induction of emesis and gastric lavage may be performed if the patient is alert and seen within early hours after ingestion. Drug remaining in the stomach may be absorbed by the administration of activated charcoal. Since the effects of AlleRx last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary.

DOSAGE AND ADMINISTRATION

Adults and adolescents 12 years of age and over: One white AM tablet in the morning and one blue PM tablet in the evening. AlleRx is not recommended for children under 12 years of age.

HOW SUPPLIED

(NDC 10122-704-20) AlleRx DF Tablets 10 Day Treatment Regimen, containing 20 tablets as follows:
10 white elongated and scored AM tablets debossed with “CBP” on one side and “03” to the right of the score on the other side, each containing 4 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate. 10 blue, elongated and scored PM tablets debossed with “CBP” on one side and “02” to the right of the score on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.

(NDC 10122-704-60) AlleRx DF Tablets 30 Day Treatment Regimen, containing 60 tablets as follows:
30 white elongated and scored AM tablets debossed with “CBP” on one side and “03” to the right of the score on the other side, each containing 4 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate. 30 blue, elongated and scored PM tablets debossed with “CBP” on one side and “02” to the right of the score on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.

(NDC 10122-704-02) AlleRx DF Tablets 2-pack sample containing 1 white AM tablet and 1 blue PM tablet per sample.

Keep out of reach of pediatric population.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° – 30° C (59° – 86° F). See USP Controlled Room Temperature.

Distributed by Cornerstone Therapeutics Inc., Cary, NC 27518.

Patent Pending

Rx Only

CORNERSTONE THERAPEUTICS INC.™

© 2009 Cornerstone Therapeutics Inc., Cary, NC 27518
CTA725F0109

ALLERX  DOSE PACK DF
chlorpheniramine maleate, methscopolamine nitrate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10122-704
Packaging
# Item Code Package Description
1 NDC:10122-704-20 1 BLISTER PACK (1 BLISTER PACK) in 1 DOSE PACK
1 1 KIT (1 KIT) in 1 BLISTER PACK
2 NDC:10122-704-60 3 BLISTER PACK (3 BLISTER PACK) in 1 DOSE PACK
2 1 KIT (1 KIT) in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 10 
Part 2 10 
Part 1 of 2
AM DOSE 
chlorpheniramine maleate, methscopolamine nitrate tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate 4 mg
methscopolamine nitrate (methscopolamine) methscopolamine nitrate 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Hypromelloses  
Anhydrous Dibasic Calcium Phosphate  
Talc  
Stearic Acid  
Magnesium Stearate  
Product Characteristics
Color white (white) Score 2 pieces
Shape OVAL (OVAL) Size 7mm
Flavor Imprint Code CBP;03
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2006
Part 2 of 2
PM DOSE 
chlorpheniramine maleate, methscopolamine nitrate tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate 8 mg
methscopolamine nitrate (methscopolamine) methscopolamine nitrate 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Hypromelloses  
Anhydrous Dibasic Calcium Phosphate  
Talc  
FD&C Blue No. 1  
Stearic Acid  
Magnesium Stearate  
Product Characteristics
Color blue (blue) Score 2 pieces
Shape OVAL (OVAL) Size 7mm
Flavor Imprint Code CBP;02
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2006
Labeler - Cornerstone Therapeutics Inc. (153886994)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, Ltd. 623168267 MANUFACTURE
Revised: 04/2011
 
Cornerstone Therapeutics Inc.

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