Country: United States
Language: English
Source: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Acme United Corporation
ASPIRIN
ASPIRIN 250 mg
ORAL
OTC DRUG
Pain reliever/fever reducer Pain reliever/fever reducer Pain reliever aid For the temporary relief of minor aches and pauns associated with - headache - muscular aches - minor arthritis pain - back pain - common cold - toothache - menstrual cramps Temporarily reduces fever.
OTC monograph not final
PHYSICIANS CARE EXTRA STRENGTH PAIN RELIEVER- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED ACME UNITED 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._ ---------- PHYSICIANS CARE EXTRA STRENGTH PAIN RELIEVER _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH TABLET)_ Acetaminophen 250 mg Aspirin (NSAID*) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug _PURPOSE_ Pain reliever/fever reducer Pain reliever/fever reducer Pain reliever aid _USES_ FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAUNS ASSOCIATED WITH headache muscular aches minor arthritis pain back pain common cold toothache menstrual cramps TEMPORARILY REDUCES FEVER. _WARNINGS_ REYE'S SYNDROME: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. ALLERGY ALERT: Aspirin (NSAIDs) may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin or allergic reaction occurs, stop use and seek medical help right away. LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,0000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product STOMACH BLEEDING WARNING: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or n Read the complete document