Label: ASPIRIN 325 MG- aspirin tablet
- NDC Code(s): 0363-6453-53
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 8, 2022
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- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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
- 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 thinner (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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
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STOP USE
Stop use and ask a doctor if:
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
- an allergic reaction occurs
Seek medical help right away if:
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD & C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
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INGREDIENTS AND APPEARANCE
ASPIRIN 325 MG
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6453 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-6453-53 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 06/15/2022 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(0363-6453)