Label: ASPIRIN tablet
- NDC Code(s): 10135-729-62
- Packager: Marlex Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
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- SPL UNCLASSIFIED SECTION
- 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
· 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 directedDo not useif you are allergic to aspirin or any other pain reliever/fever reducer
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 diarrheaAsk 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 drugStop 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
· Fever gets worse or lasts more than 3 days
· Redness or swelling is present in the painful area
· Any new symptoms appear
· Ringing in the ears or a loss of hearing occurs - Directions:
- Other Information:
- Inactive Ingredients:
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10135-729 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIACETIN (UNII: XHX3C3X673) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code S;17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10135-729-62 120 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/01/2021 Labeler - Marlex Pharmaceuticals Inc. (782540215)
