Label: ASPIRIN PAIN RELIVER- aspirin tablet
- NDC Code(s): 72090-001-01
- Packager: Pioneer Life Sciences, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 9, 2023
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- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Uses:
-
Warnings:
Reye's syndrome
Children and teenagers who have or are recovering from chickenpox 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 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
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 DOCTOR
- ASK DOCTOR/PHARMACIST
-
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 for more than 10 days
- Fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- PREGNANCY
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRIN PAIN RELIVER
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72090-001 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 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TALC (UNII: 7SEV7J4R1U) STEARIC ACID D7 (UNII: T3B081197X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ACETYLTRIETHYL CITRATE (UNII: 5WBR36T90E) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color yellow Score no score Shape ROUND (Round shape Tablet) Size 7mm Flavor Imprint Code 11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72090-001-01 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 05/17/2021 Labeler - Pioneer Life Sciences, LLC (014092742)