Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)
CVS PHARMACY, INC
ORAL
OTC DRUG
OTC monograph final
CVS OVERNIGHT COLD AND FLU CLEAR AND COOL- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE SOLUTION CVS PHARMACY, INC _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._ ---------- CVS NIGHTSHIFT COLD & FLU CLEAR & COOL _DRUG FACTS_ _ACTIVE INGREDIENTS (IN_ _EACH 20 ML)_ _PURPOSES_ ACETAMINOPHEN 650 MG PAIN RELIEVER/FEVER REDUCER Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal decongestant Triprolidine HCl 2.5 mg Antihistamine USES • • • WARNINGS LIVER WARNING This product contains acetaminophen. Severe liver damage may occur if you take: ▪ ▪ temporarily relieves these common cold and flu symptoms: • • • • • • • • • • cough nasal congestion minor aches and pains sore throat headache runny nose sneezing sinus congestion and pressure itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep more than 4000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen ▪ 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 ▪ ▪ WHEN USING THIS PRODUCT ▪ ▪ • ▪ 3 or more alcoholic drinks daily while using this product skin reddening blisters rash with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. i Read the complete document