Label: LOW DOSE ASPIRIN- aspirin tablet
- NDC Code(s): 49035-563-13, 49035-563-14, 49035-563-17, 49035-563-32
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
for the temporary relief of minor aches and pains or as recommended by your doctorClose
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:
- facial swelling
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have asthma
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
Stop use and ask a doctor if
- you experienece 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
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
These could be signs of a serious condition.
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 (1-800-222-1222) right away.
- 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: do not use unless directed by a doctor
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silca, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrateClose
- Questions or comments?
- Principal Display Panel
Compare to Bayer® Low Dose Aspirin Active Ingredient†
Adult Low Dose
120 ENTERIC COATED TABLETS
Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.
Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose Aspirin.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
LOW DOSE ASPIRIN
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-563 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (ASPIRIN) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN D&C YELLOW NO. 10 HYPROMELLOSES METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS SHELLAC SODIUM BICARBONATE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE Product Characteristics Color YELLOW Score no score Shape ROUND Size 6mm Flavor Imprint Code L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-563-17 1 in 1 CARTON 1 300 in 1 BOTTLE; Combination Product Type = C112160 2 NDC:49035-563-13 2 in 1 CARTON 2 250 in 1 BOTTLE; Combination Product Type = C112160 3 NDC:49035-563-32 1 in 1 CARTON 3 120 in 1 BOTTLE; Combination Product Type = C112160 4 NDC:49035-563-14 1 in 1 CARTON 4 500 in 1 BOTTLE; Combination Product Type = C112160 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/12/2008 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(49035-563) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(49035-563)