Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
McKesson (Sunmark)
ORAL
OTC DRUG
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
OTC monograph final
PAIN RELIEVER PM EXTRA STRENGTH- ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, COATED MCKESSON (SUNMARK) _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 GELTAB) ACETAMINOPHEN 500 MG Diphenhydramine HCl 25 mg PURPOS E PAIN RELIEVER Nighttime sleep-aid US ES temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness 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 DO NOT USE with other products 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 skin in children under 12 years of age ASK A DOCTOR BEFORE USE IF YOU HAVE liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking the blood thinning drug warfarin taking sedatives or tranquilizers WHEN USING THIS PRODUCT drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery STOP USE AND ASK A DOCTOR IF sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right read_full_document