Land: USA
Sprog: 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)
Rite Aid Corporation
ORAL
OTC DRUG
- 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 - 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
OTC monograph final
RITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION 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 NIGHTTIME SEVERE COLD & COUGH RELIEF _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH_ _PACKET)_ _PURPOSES_ Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant US ES 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 WARNINGS 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. LIVER WARNING This product contains acetaminophen. Severe liver damage may occur if you take 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 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 in a child under 4 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 pharmacist. with any other product containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Park Læs hele dokumentet