Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Medex Merchandising LLC
CAFFEINE
CAFFEINE 65 mg
OTC DRUG
OTC monograph not final
PAIN AWAY PLUS- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED MEDEX MERCHANDISING LLC _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._ ---------- MEDEX PAIN AWAY PLUS _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 PAINS 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 (NSAID) may cause a severe allergic reaction which may include: ■ hives ■ skin reddening ■ facial swelling ■ rash ■ asthma (wheezing) ■ shock ■ blisters If an 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 4,000 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 nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic Read the complete document