ENTERIC ASPIRIN- aspirin tablet, coated
GREAT LAKES WHOLESALE, MARKETING, & SALES, 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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Use(s)
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for the temporary relief of minor aches and pains due to:
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headache
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muscle pain
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toothache
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menstrual pain
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the common cold
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minor pain of arthritis
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:
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hives
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facial swelling
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shock
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asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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are age 60 or older
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have had stomach ulcers or bleeding problems
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take a blood thinning (anticoagulant) or steroid drug
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take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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have 3 or more alcoholic drinks every day while using this product
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take more or for a longer time than directed
Ask a doctor before use if
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stomach bleeding warning applies to you
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you have a history of stomach problems, such as heartburn
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you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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you have asthma
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you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
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gout
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diabetes
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arthritis
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
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- redness or swelling is present
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Directions
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drink a full glass of water with each dose
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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.
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children under 12 years: do not use unless directed by a doctor
Other information
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store in a cool dry place at controlled room temperature 15°-30°C (59°-86°F)
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use by expiration date on package
Inactive ingredients
black iron oxide, cellulose, colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Principal Display Panel
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
HEALTHCARE™
NDC 64092-141-50
REGULAR STRENGTH
ENTERIC
ASPIRIN
Pain Reliever (NSAID)
Regular Strength For Aspirin Therapy Users
SEE NEW WARNINGS INFORMATION
†Compare to the active ingredient in Ecotrin® Tablets
50 TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV0110C22715
Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
Product Packaging
| ENTERIC ASPIRIN
aspirin tablet, coated |
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| Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) |