acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl
acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including Topcare Day Time Nite Time Cold and Flu, basic care daytime severe cold and flu nighttime severe cold and flu, GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME. Available dosage form: kit.
Drug Details
- Generic Name
- acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl
- Brand Names
- Topcare Day Time Nite Time Cold and Flu, basic care daytime severe cold and flu nighttime severe cold and flu, GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME
- Application Number
- M012
- Sponsor
- Topco Associates LLC
- NDC Codes
- 3
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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 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, 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 • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.