Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
COSTCO WHOLESALE CORPORATION
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
ACETAMINOPHEN PM- ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, COATED COSTCO WHOLESALE 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._ ---------- KIRKLAND 44-556-ACETAMINOPHEN PM _ACTIVE INGREDIENTS (IN EACH GELCAP)_ 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 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. 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. in children under 12 years of age with any other product containing diphenhydramine, even one used on skin if you have ever had an allergic reaction to this product or any of its ingredients ASK A DOCTOR BEFORE USE IF YOU HAVE liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers taking the blood thinning drug warfarin 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 new symptoms occur redness or swelling is present sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. pain gets worse or Read the complete document