Label: BAYER GENUINE ASPIRIN- aspirin tablet
- NDC Code(s): 0280-2000-10, 0280-2000-20, 0280-2000-24, 0280-2000-50
- 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.
Updated October 26, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
Pain reliever/fever reducerClose
- muscle pain
- menstrual pain
- pain and fever of colds
- minor pain of arthritis
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.
Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- 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 directed
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
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
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
- children under 12 years: consult a doctor
- Other information
- save carton for full directions and warnings
- store at room temperature
- Inactive ingredients
- Questions or comments?
(Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.comClose
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
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ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER
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- INGREDIENTS AND APPEARANCE
BAYER GENUINE ASPIRIN
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2000 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 CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POWDERED CELLULOSE (UNII: SMD1X3XO9M) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code BAYER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-2000-24 1 in 1 CARTON 07/31/2014 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0280-2000-50 1 in 1 CARTON 07/31/2014 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0280-2000-10 1 in 1 CARTON 07/31/2014 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0280-2000-20 1 in 1 CARTON 07/31/2014 4 200 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 07/31/2014 Labeler - Bayer HealthCare LLC. (112117283) Establishment Name Address ID/FEI Business Operations Bayer HealthCare LLC Consumer Care 072827066 manufacture(0280-2000) , pack(0280-2000)