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)
L. Perrigo Company
OTC DRUG
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant Pain reliever/fever reducer Antihistamine Nasal decongestant
OTC monograph final
BASIC CARE DAYTIME SEVERE COLD NIGHTTIME COLD AND FLU- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE L. PERRIGO COMPANY _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._ ---------- AMAZON DAY TIME SEVERE COLD NIGHT TIME COLD & FLU DRUG FACTS ACTIVE INGREDIENTS (IN EACH CAPLET) - DAY TIME SEVERE COLD Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg ACTIVE INGREDIENTS (IN EACH CAPLET) – NIGHT TIME COLD & FLU Acetaminophen 325 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 5 mg PURPOSES - DAY TIME SEVERE COLD Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant PURPOSES - NIGHT TIME COLD & FLU Pain reliever/fever reducer Antihistamine Nasal decongestant US ES • • • • • • • • temporarily relieves these common cold and flu symptoms: nasal congestion cough (DAY TIME Severe Cold only) minor aches and pains headache sore throat runny nose and sneezing (NIGHT TIME Cold & Flu only) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of • WARNINGS LIVER WARNING: These products contain acetaminophen. Severe liver damage may occur if you take • • • 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 bothersome mucus and make coughs more productive (DAY TIME Severe Cold only) temporarily reduces fever more than 4,000 mg of acetaminophen 阅读完整的文件