Allergy DN 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

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.

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.

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.

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

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.