Label: ASPIRIN LOW STRENGTH, ENTERIC- aspirin tablet, coated
- NDC Code(s): 59779-439-29, 59779-439-51
- Packager: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
- 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 October 13, 2015
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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 due to:
- muscle pain
- menstrual pain
- the common cold
- minor pain of arthritis
- or as recommended by your doctor
- for the temporary relief of minor aches and pains due to:
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:
- 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 ever 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 or 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
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
- 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
- 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 complication 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)
- avoid excessive heat and humidity
- see end flap for expiration date and lot number
- Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrateClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredient in Ecotrin® 81 mg Low Strength Aspirin†
Pain reliever (NSAID)
365 ENTERIC COATED TABLETS Actual Size Safety coated
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Ecotrin® 81 mg Low Strength Aspirin.
Distributed by: CVS/pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com 1-800-SHOP CVS
- INGREDIENTS AND APPEARANCE
ASPIRIN LOW STRENGTH, ENTERIC
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-439 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color ORANGE Score no score Shape ROUND Size 8mm Flavor Imprint Code L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-439-29 1 in 1 CARTON 1 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:59779-439-51 1 in 1 CARTON 2 365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 04/14/2004 Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(59779-439) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(59779-439)