Label: ADULT LOW DOSE ASPIRIN 81 MG- aspirin tablet, delayed release
- NDC Code(s): 69517-001-05, 69517-001-10
- Packager: HealthLife of USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 12, 2025
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses:
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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
- shock
- 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
- you have asthma
- 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
Ask a doctor or 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.
- an allergic reaction occurs. Seek medical help right away.
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days.
- fever gets worse or lasts for more than 3 days.
- redness or swelling present in the painful area.
- new symptoms occur. These could be sign of a serious condition.
If pregnant or breast-feeding,
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.
- Directions
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INGREDIENTS AND APPEARANCE
ADULT LOW DOSE ASPIRIN 81 MG
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-001 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) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69517-001-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2025 2 NDC:69517-001-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/12/2025 Labeler - HealthLife of USA LLC (079656178) Registrant - HealthLife of USA LLC (079656178) Establishment Name Address ID/FEI Business Operations ELYSIUM PHARMACEUTICALS LIMITED 863182240 manufacture(69517-001) Establishment Name Address ID/FEI Business Operations HHH PHARMA USA LLC 062788820 pack(69517-001)
