BAYER LOW DOSE- aspirin tablet 
Bayer HealthCare LLC.

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.

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Bayer ® Low Dose Aspirin Regimen

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

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 if you are allergic to aspirin or any other pain reliever/fever reducer

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 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

black iron oxide, brown iron oxide, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer type C, polysorbate 80, powdered cellulose, propylene glycol, shellac, sodium lauryl sulfate, triacetin, triethyl citrate

Questions or comments?

1-800-331-4536 (Mon - Fri 9AM - 5PM EST) or www.bayeraspirin.com

PRINCIPAL DISPLAY PANEL - 32 Tablet Bottle Carton

N 0280-2100-32

ASPIRIN REGIMEN



BAYER
®



ASPIRIN (NSAID) PAIN RELIEVER

LOW DOSE

81mg

Safety Coated



Aspirin

32 ENTERIC COATED TABLETS

Carton 200 count

BAYER  LOW DOSE
aspirin tablet
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)

Revised: 9/2017
Document Id: 58757b5b-37e9-7192-e053-2a91aa0aaf68
Set id: 075b103e-0bb4-4b7a-ac0e-5645bcbd0a07
Version: 4
Effective Time: 20170905
 
Bayer HealthCare LLC.