国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Topco Associates LLC
ORAL
OTC DRUG
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
OTC monograph final
TOPCARE DAY TIME COLD AND FLU- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED TOPCO ASSOCIATES LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- TOPCO ASSOCIATES LLC. DAY TIME COLD & FLU DRUG FACTS ACTIVE INGREDIENTS (IN EACH CAPLET) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg PURPOSE Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant USES • • • • • • • • • • • • WARNINGS LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if you take 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 • • • ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms may include: • • • 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. DO NOT USE • • • ASK A DOCTOR BEFORE USE IF YOU HAVE • • • • • • • • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking the blood thinning drug warfarin WHEN USING THIS PRODUCT DO NOT USE MORE THAN DIRECTED STOP USE AND ASK A DOCTOR IF • 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 skin redd 阅读完整的文件