Allergy DN II

Day Dose - 4 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate
Night Dose - 8 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate

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

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 if 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 or methscopolamine nitrate. This product is also contraindicated in nursing mothers, and in patients with the following conditions: severe coronary artery disease; narrow-angle glaucoma; urinary retention; hyperthyroidism; peptic ulcer; asthma attack; MAOI therapy (or for 2 weeks after stopping MAOI therapy).

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. Methscopolamine nitrate may produce dizziness 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. Alkylamine-type antihistamines should be used with extreme caution in patients with narrow-angle glaucoma; stenosing peptic ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy, or bladder neck obstruction. Due to its mild atropine-like action, chlorpheniramine should be used cautiously in patients with bronchial asthma, emphysema, or chronic pulmonary disease. May cause excitability, especially in children.

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 II™ and sildenafil citrate has not been studied. Therefore, the use of sildenafil citrate and Allergy DN II™ together is not recommended.

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 Allergy DN II™ last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary.

Allergy DN II™ is supplied in boxes of 20 tablets NDC #51991-534-20 One blister card of 10 Day Tablets NDC # 51991-533-17, and one blister card of 10 Night tablets NDC #51991-489-17.

Day tablets are beige, oval-shaped and scored, debossed with B 533.

Night tablets are green, oval-shaped and scored, debossed with B 489.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

PHARMACIST: Dispense in original container.

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

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Provident Pharmaceuticals, Colorado Springs, CO 80919
Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487

Rx Only

360672501 ISS. 4/08