Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Strategic Sourcing Services LLC
ORAL
OTC DRUG
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant temporarily relieves common cold/flu symptoms:
OTC monograph final
FOSTER AND THRIVE NIGHTTIME SEVERE COLD AND FLU RELIEF- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOLUTION STRATEGIC SOURCING SERVICES 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._ ---------- MCKESSON NIGHTTIME SEVERE COLD & FLU RELIEF DRUG FACTS ACTIVE INGREDIENTS (IN EACH 15 ML) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine HCl 5 mg PURPOSE Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant USES temporarily relieves common cold/flu symptoms: • • • • • • • • • • • • WARNINGS nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation cough to help you sleep minor aches and pains sore throat headache fever runny nose and sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if • • • • 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 • • adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product skin reddening blisters rash with any other drug containing acetaminophen (prescription or nonpresc Read the complete document