The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each tablet) PurposeAspirin 325 mg (NSAID*).............................Pain reliever*nonsteroidal anti-inflammatory drug
Otc - Purpose
Indications & Usage
- Uses •for the temporary relief of minor aches and pains due to •headache •colds •muscle pain •menstrual pain •toothache •minor pain of arthritis •or as directed by your doctor
- WarningsReye'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 or 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 inclue: •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 •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
Otc - Do Not Use
- Do not use •if you are allergic to aspirin or any other pain reliever/fever reducer
Otc - Ask Doctor
- 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
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you are •taking a prescription drug for diabetes, gout, or arthritis •taking any other drugs •under a doctor's care for any serious condition
Otc - Stop Use
- Stop use and ask a doctor if •you experience any of the following signs of stomach bleeding: •feel faint •have bloody or black stools •vomit blood •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 in the painful area •any new symptoms appear •ringing in the ears or a loss of hearing occurs
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage & Administration
- Directions •drink a full glass of water with each dose •adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor •children under 12 years: consult a doctor
Storage And Handling
- Other information •store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) •use by expiration date on package
Inactive ingredients corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
Otc - Questions
Questions? To Report Adverse Drug Event Call: (800) 616-2471
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