Label: PAIN RELIEVER- aspirin 81 mg tablet, delayed release
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NDC Code(s):
69517-104-01,
69517-104-02,
69517-104-03,
69517-104-05, view more69517-104-10, 69517-104-25, 69517-104-30, 69517-104-50, 69517-104-60, 69517-104-65
- Packager: HealthLife Of USA
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 29, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER
aspirin 81 mg tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-104 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 STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (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 7mm Flavor Imprint Code A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69517-104-25 25 in 1 BOX 06/05/2017 06/05/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:69517-104-50 50 in 1 BOX 06/05/2017 06/05/2017 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:69517-104-02 2 in 1 POUCH 06/05/2017 06/05/2017 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:69517-104-01 1000 in 1 BOTTLE 06/05/2017 4 NDC:69517-104-65 365 in 1 BOTTLE 4 NDC:69517-104-30 30 in 1 BOTTLE 4 1 in 1 CARTON; Type 0: Not a Combination Product 5 NDC:69517-104-60 1 in 1 CARTON 06/05/2017 5 60 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:69517-104-03 300 in 1 BOTTLE; Type 0: Not a Combination Product 11/29/2023 7 NDC:69517-104-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/29/2023 8 NDC:69517-104-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/29/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/09/2016 Labeler - HealthLife Of USA (079656178) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceutical Ltd. 915664486 manufacture(69517-104) Establishment Name Address ID/FEI Business Operations Health Pharma USA LLC 080804485 manufacture(69517-104)