Acetaminophen, Diphenhydramine HCl, Phenylephrine HCI

FDA Drug Profile — Defensol D Blister Pack

Drug Details

Generic Name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCI
Brand Names
Defensol D Blister Pack
Application Number
M012
Sponsor
Menper Distributors, Inc.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses Temporarily relieves these symptoms associated with cold or flu: headache nasal congestion sore throat fever minor aches and pains Temporarily relieves minor aches, pains, and headache as well as those symptoms of hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itching of the nose or throat itchy, watery eyes Temporarily relieves minor aches, pains, headache, and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages

Warnings

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in any 24-hour period, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Severe throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Allergy alert : Acetaminophen may cause severe skin reactions: Symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away.