Label: BAYER LOW DOSE- aspirin tablet
0280-2100-32, view more0280-2100-40
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 5, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
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 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
- 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.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 32 Tablet Bottle Carton
INGREDIENTS AND APPEARANCE
BAYER LOW DOSE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) CARNAUBA WAX (UNII: R12CBM0EIZ) BROWN IRON OXIDE (UNII: 1N032N7MFO) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POWDERED CELLULOSE (UNII: SMD1X3XO9M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow Score no score Shape ROUND Size 5mm Flavor Imprint Code 81 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-2100-32 1 in 1 CARTON 07/12/2002 1 32 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0280-2100-12 1 in 1 CARTON 07/12/2002 2 120 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0280-2100-20 1 in 1 CARTON 07/12/2002 3 200 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0280-2100-30 1 in 1 CARTON 07/12/2002 4 300 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0280-2100-40 1 in 1 CARTON 07/12/2002 5 400 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 final part343 07/12/2002 Labeler - Bayer HealthCare LLC. (112117283) Establishment Name Address ID/FEI Business Operations Bayer HealthCare LLC Consumer Care 072827066 manufacture(0280-2100) , pack(0280-2100)