Country: United States
Language: English
Source: 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)
COSTCO WHOLESALE CORPORATION
ACETAMINOPHEN
ACETAMINOPHEN 325 mg
OTC DRUG
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant - temporarily relieves these common cold and flu symptoms: cough headache sore throat minor aches and pains nasal congestion sinus congestion and pressure (Nighttime only) sneezing and runny nose (Nighttime only) - cough - headache - sore throat - minor aches and pains - nasal congestion - sinus congestion and pressure (Nighttime only) - sneezing and runny nose (Nighttime only) - help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only) - helps clear nasal passages (Nighttime only) - relieves cough to help you sleep (Nighttime only) - temporarily reduces fever
OTC monograph final
COLD AND FLU MULTI-SYMPTOM DAYTIME/NIGHTTIME SEVERE- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN AND PHENYLEPHRINE HCL COSTCO WHOLESALE CORPORATION _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._ ---------- KIRKLAND 44-503A473C _ACTIVE INGREDIENTS (IN EACH CAPLET)_ _(DAYTIME COLD & FLU SEVERE)_ Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg _PURPOSE_ Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant _ACTIVE INGREDIENTS (IN EACH CAPLET)_ _(NIGHTTIME COLD & FLU SEVERE)_ Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg _PURPOSE_ Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant _USES_ temporarily relieves these common cold and flu symptoms: cough headache sore throat minor aches and pains nasal congestion sinus congestion and pressure _(NIGHTTIME ONLY)_ sneezing and runny nose _(NIGHTTIME ONLY)_ help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive _(DAYTIME_ _ONLY)_ helps clear nasal passages _(NIGHTTIME ONLY)_ relieves cough to help you sleep _(NIGHTTIME ONLY)_ temporarily reduces fever _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 3 or more alcoholic drinks every day while using this product with other drugs containing acetaminophen 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. DO NOT USE with any other drug containing acetaminop Read the complete document