Low Dose Aspirin 81 mg (Delayed-Release Enteric Coated)
Drug Labeling and Warnings
Drug Details [pdf]
LOW DOSE ASPIRIN- aspirin tablet
Preferred Pharmaceuticals, 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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Low Dose Aspirin 81 mg (Delayed-Release Enteric Coated)
USES
for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches 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 very serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
if an allergic reaction occurs, stop use and seek medical help right away.
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
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 have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
Taking a prescription drug for:
- anticoagulation (thinning of the blood)
- diabetes
- gout
- 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
- new symptoms occur
- redness or swelling is present
- Ringing in the ears or loss of hearing occurs
- Pain gets worse or lasts for more than 10 days
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
OTHER INFORMATION
- store at room temperature
- do not use if imprinted safety seal under cap is broken or missing
You may report side effects to: 1-888-952-0050.
INACTIVE INGREDIENTS
anhydrous lactose, carnauba wax, croscarmlellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, silicon dioxide, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
| LOW DOSE ASPIRIN
aspirin tablet |
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| Labeler - Preferred Pharmaceuticals, Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals, Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals, Inc. | 791119022 | REPACK(68788-9671) | |