DRUG FACTS
Drug Labeling and Warnings
Drug Details [pdf]
ASPIRIN ENTERIC COATED- aspirin tablet, coated
Publix Supermarkets, Inc.
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.
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DRUG FACTS
Uses
- temporarily relieves minor aches and pains
- other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.
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
- asthma (wheezing)
- shock
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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
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:
- anticoagulation (thinning of the blood)
- gout
- diabetes
- arthritis
Stop use and ask a doctor if
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
- allergic reaction occurs
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- any new symptoms appear
- redness or swelling is present in the painful area
Directions
- do not exceed recommended dosage
- drink a full glass of water with each dose
- adults and children 12 years of age 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 of age: consult a doctor
Inactive ingredients
acetylated monoglycerides**, anhydrous lactose**, carnauba wax**, colloidal silicon dioxide, corn starch**, croscarmellose sodium**, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, hypromellose phthalate**, iron oxide Yellow (iron oxide ochre)**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, polyethylene glycol (PEG)-400**, polysorbate 80**, povidone, pregelatinized starch, propylene glycol**, simethicone**, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, and triethyl citrate
**contains one or more of these ingredients
Principal Display Panel
ENTERIC SAFETY COATED
aspirin 81 mg
LOW DOSE ASPIRIN REGIMEN ‡
PAIN RELIEVER (NSAID)*
- Adult Low Dose
ENTERIC COATED TABLETS
Compare to the active ingredient in Aspirin Regimen Bayer® 81 mg†
†This product is not manufactured or distributed by Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg
‡ Ask your doctor before taking this product on a regular basis.
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.
3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811
publix.com
KEEP OUTER CARTON FOR COMPLETE WARNINGS & PRODUCT INFORMATION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
| ASPIRIN
ENTERIC COATED
aspirin tablet, coated |
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| Labeler - Publix Supermarkets, Inc. (006922009) |
| Registrant - P & L Development, LLC (800014821) |