Complete SPL Sections
OTC - ACTIVE INGREDIENT SECTION
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever *nonsteroidal anti-inflammatory drug
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT SECTION
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
OTC - PURPOSE SECTION
OTC - PURPOSE SECTION
Uses • temporarily relieves minor aches and pains • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
DOSAGE & ADMINISTRATION SECTION
DOSAGE & ADMINISTRATION SECTION
Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
OTC - ASK DOCTOR SECTION
OTC - ASK DOCTOR SECTION
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 • you have not been drinking fluids • you have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout, or arthritis • under a doctor’s care for any serious condition • taking any other drug
OTC - ASK DOCTOR/PHARMACIST SECTION
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout, or arthritis • under a doctor’s care for any serious condition • taking any other drug
OTC - PREGNANCY OR BREAST FEEDING SECTION
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
INDICATIONS & USAGE SECTION
Uses temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
WARNINGS SECTION
WARNINGS SECTION
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 facial swelling shock asthma (wheezing) 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 have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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