doxylamine succinate

FDA Drug Profile — topcare sleep aid, sleep aid, good sense sleep aid ultra

Drug Details

Generic Name
doxylamine succinate
Brand Names
topcare sleep aid, sleep aid, good sense sleep aid ultra
Application Number
ANDA040167
Sponsor
Topco Associates LLC
NDC Codes
4
Dosage Forms
TABLET, COATED, TABLET
Routes
ORAL
Active Ingredients
DOXYLAMINE SUCCINATE

Indications and Usage

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat nasal congestion sinus congestion and pressure temporarily reduces fever Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough nasal congestion runny nose sneezing sore throat sinus congestion and pressure temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take -more than 4,000 mg of acetaminophen in 24 hours -with other drugs containing acetaminophen -3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: -skin reddening -blisters -rash -hives -facial swelling -asthma (wheezing) -shock If a skin or general allergic reaction occurs, stop use and seek medical help right away. Sore 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. Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin or general allergic reaction occurs, stop use and seek medical help right away. Sore 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. Do not use to sedate children.