Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Healthlife of USA
ORAL
OTC DRUG
Pain reliever/ Fever reducer Temporarily relieves minor aches and pains due to: - headache - muscular aches - backache - minor pain of arthritis - the common cold - toothache - temporarily reduces fever - premenstrual and menstrual cramps - with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. - if you are allergic to acetaminophen or any of the inactive ingredients in this product. liver disease taking the blood thinning drug warfarin - pain gets worse or lasts more than 10 days - fever gets worse or lasts more than 3 days - new symptoms occur - redness or swelling is present These could be signs of a serious condition.
OTC monograph not final
REGULAR STRENGTH PAIN RELIEVER- ACETAMINOPHEN TABLET HEALTHLIFE OF USA _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._ ---------- PAIN RELIEVER REGULAR STRENGTH DRUG FACTS ACTIVE INGREDIENT (IN EACH TABLET) Acetaminophen 325mg PURPOS E Pain reliever/ Fever reducer US ES Temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache temporarily reduces fever premenstrual and menstrual cramps WARNINGS LIVER WARNING: This product contains acetaminophen. The maximum daily dose of this product is 9 tablets (2925 mg) in 24 hours. Severe liver damage may occur if you take: more than 3000mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs; stop use and seek medical help right away. DO NOT USE with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product. ASK DOCTOR BEFORE USE IF YOU HAVE liver disease ASK YOUR DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking the blood thinning drug warfarin STOP USE AND ASK A DOCTOR IF: pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick Read the complete document