Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
RARITAN PHARMACEUTICALS INC
ORAL
OTC DRUG
Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant
OTC monograph final
NIGHTTIME SEVERE COLD AND COUGH- ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE POWDER, FOR SOLUTION RARITAN PHARMACEUTICALS 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._ ---------- DRX CHOICE NIGHTTIME SEVERE COLD & COUGH CHAMOMILE & WHITE TEA FLAVORS 6 PACKETS ACTIVE INGREDIENTS (IN EACH PACKET) Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg PURPOSES Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant USES ▪ ▪ WARNINGS LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if you take ▪ temporarily relieves these symptoms due to a cold: ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever more than 4,000 mg of acetaminophen in 24 hours ▪ ▪ 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 ▪ ▪ with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product skin reddening blisters rash in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist. with any other product Les hele dokumentet