Država: Združene države Amerike
Jezik: angleščina
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)
Rite Aid Corporation
ORAL
OTC DRUG
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
OTC monograph final
SEVERE COLD AND FLU RELIEF NIGHTTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED RITE AID 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._ ---------- RITE AID CORPORATION NIGHTTIME SEVERE COLD & FLU RELIEF DRUG FACTS ACTIVE INGREDIENTS (IN EACH CAPLET) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg PURPOS E Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant US ES • • • • • • • • • • • • • WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • • • temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation cough to help you sleep minor aches and pains headache fever sore throat runny nose and sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 • • • • • • STOP USE AND ASK A DOCTOR IF skin reddening blisters rash with any other drug containing acetaminophen (prescription or nonprescription). If Preberite celoten dokument