Label: BAYER HEADACHE- aspirin and caffeine tablet
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- NDC Code(s): 0280-0064-01, 0280-0064-02
- Packager: Bayer HealthCare 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 October 17, 2022
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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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 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 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
Ask a doctor or pharmacist before use if you are taking a prescription drug for
● gout
● diabetes
● arthritis
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Package Display 50 Count Carton
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INGREDIENTS AND APPEARANCE
BAYER HEADACHE
aspirin and caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0064 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.5 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) POWDERED CELLULOSE (UNII: SMD1X3XO9M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 30 (UNII: 2S42T2808B) TRIACETIN (UNII: XHX3C3X673) SHELLAC (UNII: 46N107B71O) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code Bayer;Headache Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0064-01 1 in 1 CARTON 04/28/2021 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0280-0064-02 1 in 1 CARTON 04/28/2021 2 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/28/2021 Labeler - Bayer HealthCare LLC. (112117283)
