Label: BAYER ASPIRIN EXTRA STRENGTH CAPLETS- bayer aspirin extra strength tablet
- NDC Code(s): 0280-2020-10
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
-
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 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
- 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 more than 10 days
- redness or swelling is present
- fever lasts more than 3 days
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients
- QUESTIONS
- Carton 100 caplets
-
INGREDIENTS AND APPEARANCE
BAYER ASPIRIN EXTRA STRENGTH CAPLETS
bayer aspirin extra strength tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSES (UNII: 3NXW29V3WO) POWDERED CELLULOSE (UNII: SMD1X3XO9M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code Extra;Strength;BAYER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-2020-10 1 in 1 CARTON 12/23/2014 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 12/23/2014 Labeler - Bayer HealthCare LLC. (112117283) Establishment Name Address ID/FEI Business Operations Bayer HealthCare LLC Consumer Care 072827066 manufacture(0280-2020) , pack(0280-2020)