Allergy DN PE

Name: Allergy DN PE

AllergyDN PE™

Day Dose - 40 mg phenylephrine HCl and 2.5 mg methscopolamine nitrate
Night Dose - 10 mg phenylephrine HCl, 8 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate

Allergy DN PE - Clinical Pharmacology

Chlorpheniramine maleate is an alkylamine-type antihistamine that possesses anticholinergic and sedative effects. Antihistamines competitively antagonize histamine at the H1 receptor site. Thus, activation of H1 receptors by released histamine which results in increased vascular permeability, increased mucus production, pruritus and sneezing is prevented.

Phenylephrine is a sympathomimetic amine, acts directly on adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction that increases peripheral resistance, resulting in an increase in both systolic and diastolic blood pressure. Accompanying the pressor response is a marked reflex bradycardia due to increased vagal activity. It produces vasoconstriction that lasts longer than that produced by ephedrine and epinephrine, and in therapeutic doses, produces little or no central nervous system (CNS) stimulation. Phenylephrine has reduced bioavailability from the gastrointestinal tract because of first pass metabolism by monoamine oxidase in the stomach and liver.

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. It competitively inhibits the action of acetylcholine at muscarinic receptors.

Contraindications

This product is contraindicated in patients with a hypersensitivity or idiosyncratic reaction to chlorpheniramine maleate, methscopolamine nitrate or phenylephrine hydrochloride. This product is also contraindicated in nursing mothers, and in patients with the following conditions: severe hypertension; severe coronary artery disease; narrow-angle glaucoma; urinary retention; hyperthyroidism; peptic ulcer; asthma attack; MAOI therapy (or for 2 weeks after stopping MAOI therapy). Sympathomimetic amines may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetic amines in overdosage may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage.

Antihistamines should be used with considerable caution in pyloroduodenal obstruction; symptomatic prostatic hypertrophy; bladder neck obstruction. 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.

Heat prostration can occur with methscopolamine used where the environmental temperature is high. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, use of methscopolamine would be inappropriate and possibly harmful.

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

PRINCIPAL DISPLAY PANEL - 20 tablet carton

Breckenridge
Pharmaceutical, Inc.

NDC 51991-558-20

AllergyDN PE™

Day Dose - 40 mg phenylephrine HCl and 2.5 mg methscopolamine nitrate
Night Dose - 10 mg phenylephrine HCl, 8 mg chlorpheniramine maleate and
2.5 mg methscopolamine nitrate

Day Dose - 40 mg phenylephrine HCl and 2.5 mg methscopolamine nitrate
Night Dose - 10 mg phenylephrine HCl, 8 mg chlorpheniramine maleate and
2.5 mg methscopolamine nitrate

20 Tablets containing the Following:

10 Yellow Day Tablets each contain:   10 Dark Green Night Tablets each contain:
Phenylephrine HCl................ 40 mg    Phenylephrine HCl.................. 10 mg
Methscopolamine Nitrate......2.5 mg    Chlorpheniramine Maleate......8 mg
                                                           Methscopolamine Nitrate......2.5 mg

20 Tablets (2 blister cards of 10 tablets)

Rx Only

Allergy DN PE 
phenylephrine hydrochloride, methscopolamine nitrate and chlorpheniramine maleate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-558
Packaging
# Item Code Package Description
1 NDC:51991-558-20 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK 10 
Part 2 1 BLISTER PACK 10 
Part 1 of 2
DAY DOSE 
phenylephrine hydrochloride, methscopolamine nitrate tablet
Product Information
Item Code (Source) NDC:51991-556
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 40 mg
Methscopolamine Nitrate (Methscopolamine) Methscopolamine Nitrate 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Dibasic Calcium Phosphate Dihydrate  
Cellulose, Microcrystalline  
FD&C Yellow no. 5  
Hypromellose  
Silicon Dioxide  
Croscarmellose Sodium  
Magnesium Stearate  
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code B;556
Contains     
Packaging
# Item Code Package Description
1 NDC:51991-556-17 10 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/01/2008
Part 2 of 2
NIGHT DOSE 
phenylephrine hydrochloride, methscopolamine nitrate and chlorpheniramine maleate tablet
Product Information
Item Code (Source) NDC:51991-557
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
Methscopolamine Nitrate (Methscopolamine) Methscopolamine Nitrate 2.5 mg
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 8 mg
Inactive Ingredients
Ingredient Name Strength
Dibasic Calcium Phosphate Dihydrate  
Cellulose, Microcrystalline  
FD&C Yellow no. 5  
FD&C Blue no. 1  
Hypromellose  
Silicon Dioxide  
Croscarmellose Sodium  
Magnesium Stearate  
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code B;557
Contains     
Packaging
# Item Code Package Description
1 NDC:51991-557-17 10 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/01/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/01/2008
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Provident Pharmaceuticals, LLC 171901445 MANUFACTURE
Revised: 10/2009   Breckenridge Pharmaceutical, Inc.

For the Consumer

Applies to chlorpheniramine / methscopolamine / phenylephrine: oral tablet chewable, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking chlorpheniramine / methscopolamine / phenylephrine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • little or no urinating;

  • fast, pounding, or irregular heartbeats;

  • pale skin, weakness, feeling short of breath; or

  • tremors, hallucinations, severe anxiety.

Common side effects may include:

  • blurred vision, headache, dizziness;

  • dry mouth, nose, or throat;

  • nausea; or

  • feeling nervous or restless.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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