ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY. Available dosage form: capsule, gelatin coated.
Drug Details
- Generic Name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE
- Brand Names
- DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY
- Application Number
- M012
- Sponsor
- Advanced Rx LLC
- NDC Codes
- 1
- Dosage Forms
- CAPSULE, GELATIN COATED
- Routes
- ORAL
- Active Ingredients
- DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN
Indications and Usage
Uses Temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pain • fever
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take•more than 8 softgels in 24 hours, which is the maximum daily amount for this product •with other drugs containing acetaminophen •3 or more alcoholic drinks daily while using this product. 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. Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.