Label: ASPIRIN- aspirin tablet
- NDC Code(s): 49781-097-52, 49781-097-58
- Packager: CARDINAL HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 11, 2017
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- Active ingredient (in each tablet)
Aspirin 81mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
- for the temporary relief of minor aches and pains or as recommneded by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
- ask your doctor about other uses for this product
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 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 are taking a diuretic
- you have asthma
- 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:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- any new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- ringing in the ears or loss of hearing occurs
These could be signs of a serious illness.
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 accidental 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 consult a doctor
- Other information
- store at room temperature
- save carton for full direction and warnings
- Inactive ingredients
croscarmellose sodium, D&C yellow# 10 Lake, FD&C yellow# 6, hypromellose, lactose, methcrylic acid copolymer, microcrystaline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethlyl citrateClose
- Questions or comments?
Adverse drug event call: (866) 562-2756Close
- PRINCIPAL DISPLAY PANEL
†Compare to Bayer® low dose aspirin active ingredient
Aspirin 81 mg
Pain Reliever (NSAID)
Low Dose Safety Coated
120 ENTERIC COATED TABLETS
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-097 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code EA8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-097-52 1 in 1 CARTON 09/20/2014 1 120 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49781-097-58 300 in 1 BOTTLE; Type 0: Not a Combination Product 09/20/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 09/20/2014 Labeler - CARDINAL HEALTH (097537435) Registrant - Pharbest Pharmaceuticals, Inc. (557054835)