国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
CARDINAL HEALTH
ACETAMINOPHEN
ACETAMINOPHEN 500 mg
ORAL
OTC DRUG
Pain reliever Nighttime sleep-aid temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
OTC monograph not final
EXTRA STRENGTH PAIN RELIEVER PM- ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET, FILM COATED CARDINAL HEALTH _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._ ---------- LEADER 44-235 _ACTIVE INGREDIENTS (IN EACH CAPLET)_ Acetaminophen 500 mg Diphenhydramine HCl 25 mg _PURPOSE_ Pain reliever Nighttime sleep-aid _USES_ 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 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 skin in children under 12 years of age if you are allergic to acetaminophen or any of the inactive ingredients in this product 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 beverages 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 a 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 O 阅读完整的文件