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)
American Sales Company
OTC DRUG
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
OTC monograph final
CAREONE DAY SEVERE COLD NIGHT COLD AND FLU- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE AMERICAN SALES 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._ ---------- CAREONE DAY SEVERE COLD NIGHT COLD & FLU DRUG FACTS ACTIVE INGREDIENTS (IN EACH LIQUID GEL) – DAY SEVERE COLD Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg PURPOSES – DAY SEVERE COLD Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant ACTIVE INGREDIENTS (IN EACH LIQUID GEL) – NIGHT COLD & FLU Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg PURPOSES – NIGHT COLD & FLU Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant US ES • • • • • • temporarily relieves these common cold and flu symptoms: cough minor aches and pains headache nasal congestion sore throat • • • • 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 • • • • • • • • • • runny nose and sneezing (NIGHT only) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only) controls cough to help you get to sleep (NIGHT only) temporarily reduces fever more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or 阅读完整的文件