Label: ASPIRIN 81 MG ENTERIC COATED- aspirin tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 10135-689-62 - Packager: Marlex Pharmaceuticals Inc
- 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.
Drug Label Information
Updated September 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
- Shock
- 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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- You are taking a diuretic
- You have asthma
- You have not been drinking fluids
- You have lost a lot of fluid due to vomiting or diarrhea
Ask a doctor or a pharmacist before use if you are
- Taking a prescription drug for diabetes, gout, or arthritis
- Under a doctor’s care for any serious condition
- Taking any other drug
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
- Pain gets worse or lasts more than 10 days
- Redness or swelling is present in the painful area
- Any new symptoms appear
- Ringing in the ears or a loss of hearing occurs
- Hives
- Directions:
- Other Information:
- Inactive Ingredients:
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRIN 81 MG ENTERIC COATED
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10135-689 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color yellow Score no score Shape ROUND Size 5mm Flavor Imprint Code A1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10135-689-62 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/01/2020 Labeler - Marlex Pharmaceuticals Inc (782540215)
