Label: ASPIRIN ENTERIC COATED- aspirin 81 mg tablet
- NDC Code(s): 83139-372-60
- Packager: Lodaat LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
-
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:
- hives
- facial swelling
- asthma (wheezing)
- shock
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 non prescription 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
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if
- taking a prescription drug for anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
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
- pain gets worse or lasts more than10 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- You may report side effects to 1-888-952-0050
Pregnancy/Breastfeeding
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
specifically directed to do so by a doctor because it may cause problems in the
unborn child or complications during delivery.
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ASPIRIN ENTERIC COATED
aspirin 81 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83139-372 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) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHACRYLIC ACID (UNII: 1CS02G8656) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83139-372-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/31/2023 Labeler - Lodaat LLC (011845714)
