doxylamine succinate
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.