PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 50 Caplet Carton ASPIRIN (NSAID) / PAIN RELIEVER CAFFEINE / PAIN RELIEVER AID BAYER HEADACHE RELIEF OFFICIAL SPONSOR 50 Coated Caplets FAST, SAFE HEADACHE RELIEF DUAL ACTION FORMULA
OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each caplet) Purpose Aspirin 500 mg (NSAID)nonsteroidal anti-inflammatory drug Pain reliever Caffeine 32.5 mg Pain reliever aid
INDICATIONS & USAGE SECTION.
Uses for the temporary relief of headache muscle aches and pains
DOSAGE & ADMINISTRATION SECTION.
Directions drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours not to exceed 8 caplets in 24 hours children under 12 years: consult a doctor
SPL UNCLASSIFIED SECTION.
INACTIVE INGREDIENT SECTION.
Inactive ingredients carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin
STORAGE AND HANDLING SECTION.
Other information save carton for full directions and warnings store at room temperature
OTC - QUESTIONS SECTION.
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST) or www.bayeraspirin.com
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 may cause a severe allergic reaction which may include: hives asthma (wheezing) facial swelling shock 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 drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.