Label: ASPIRIN ENTERIC COATED LOW DOSE- aspirin tablet, coated
view more0363-0563-27, 0363-0563-32, 0363-0563-63, 0363-0563-90
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated August 17, 2018
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- Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*Close
*nonsteroidal anti-inflammatory drug
for the temporary relief of minor aches and pains or as recommended by your doctor.Close
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
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 other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- take more or for a longer time than directed
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- have 3 or more alcoholic drinks every day while using this product
Ask a doctor before use if
- you have asthma
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- vomit blood
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
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, silica, 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††
81 mg / PAIN RELIEVER (NSAID)
**Talk to your doctor or other healthcare provider before using this product for your heart.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Walgreens Pharmacist Recommend
Walgreens Pharmacist Survey
††This product is not manufactured
or distributed by Bayer Healthcare LLC,
owner of the registered trademark Bayer®
Low Dose Aspirin.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
©2018 Walgreen Co.
- INGREDIENTS AND APPEARANCE
ASPIRIN ENTERIC COATED LOW DOSE
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0563 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) METHACRYLIC ACID (UNII: 1CS02G8656) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) SHELLAC (UNII: 46N107B71O) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIACETIN (UNII: XHX3C3X673) 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:0363-0563-27 1 in 1 CARTON 05/01/2011 1 32 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-0563-90 1 in 1 CARTON 05/01/2011 2 150 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-0563-63 2 in 1 CARTON 05/01/2011 3 120 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0363-0563-22 1 in 1 CARTON 05/01/2011 4 48 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0363-0563-06 1 in 1 CARTON 05/01/2011 5 200 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0363-0563-32 1 in 1 CARTON 05/01/2011 6 120 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0363-0563-17 1 in 1 CARTON 05/01/2011 7 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 8 NDC:0363-0563-14 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/01/2011 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0563) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 MANUFACTURE(0363-0563) , PACK(0363-0563) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(0363-0563)