Land: USA
Språk: engelska
Källa: 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)
Select Brand Dist.
ACETAMINOPHEN
ACETAMINOPHEN 650 mg in 30 mL
ORAL
OTC DRUG
Pain reliever/fever reducer Antihistamine Nasal decongestant - for the temporarily relief of the following cold/flu symptoms minor aches and pains headache runny nose sneezing itching of the nose or throat sore throat nasal and sinus congestion itchy, watery eyes - minor aches and pains - headache - runny nose - sneezing - itching of the nose or throat - sore throat - nasal and sinus congestion - itchy, watery eyes - temporarily reduces fever
OTC monograph final
FLU AND SORE THROAT- ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL LIQUID SELECT BRAND DIST. _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._ ---------- DRUG FACTS ACTIVE INGREDIENTS (IN EACH 30 ML) ACETAMINOPHEN 650 MG Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg PURPOS E PAIN RELIEVER/FEVER REDUCER Antihistamine Nasal decongestant US ES for the temporarily relief of the following cold/flu symptoms minor aches and pains headache runny nose sneezing itching of the nose or throat sore throat nasal and sinus congestion itchy, watery eyes temporarily reduces fever WARNINGS 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 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 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 to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other product containing diphenhydramine, even one used on skin with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ASK A DOCTOR BEFORE USE IF YOU HAVE liver disease glaucoma heart disease thyroid disea Läs hela dokumentet