Label: ASPIRIN- aspirin tablet 325mg tablet
- NDC Code(s): 67091-382-10, 67091-382-30
- Packager: WinCo Foods LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 23, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
• 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 directedAsk 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 diarrhea
Ask a doctor or pharmacist before use if you are
• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug
• under a doctor’s care for any serious condition
Stop use and ask a doctor if
• you experience any of the following signs of stomach bleeding:
o feel faint
o have bloody or black stoolso vomit blood
o 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 - DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet 325mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-382 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 STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) MINERAL OIL (UNII: T5L8T28FGP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL011 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-382-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2022 2 NDC:67091-382-30 300 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/18/2022 Labeler - WinCo Foods LLC (056098817) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(67091-382)
