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BAYER  LOW DOSE - aspirin tablet 
Bayer HealthCare LLC, Consumer Care

Bayer® Low Dose Aspirin Regimen

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
  • ask your doctor about other uses for Bayer Safety Coated 81 mg Aspirin

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

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Other information

  • save carton for full directions and warnings
  • store at room temperature

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

Principal Display Panel - 32 Tablet Bottle Carton

BAYER   LOW DOSE
aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0280-2100
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspirin (Aspirin) Aspirin 81 mg
Inactive Ingredients
Ingredient Name Strength
Ferrosoferric Oxide  
Carnauba wax  
Brown iron oxide  
starch, corn  
D&C yellow NO. 10  
Aluminum Oxide  
FD&C yellow NO. 6  
Hypromelloses  
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A  
Polysorbate 80  
Powdered cellulose  
Propylene glycol  
Shellac  
Sodium lauryl sulfate  
Triacetin  
Triethyl citrate  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 81
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0280-2100-32 1  In 1 CARTON contains a BOTTLE
1 32  In 1 BOTTLE This package is contained within the CARTON (0280-2100-32)
2 0280-2100-12 1  In 1 CARTON contains a BOTTLE
2 120  In 1 BOTTLE This package is contained within the CARTON (0280-2100-12)
3 0280-2100-20 1  In 1 CARTON contains a BOTTLE
3 200  In 1 BOTTLE This package is contained within the CARTON (0280-2100-20)
4 0280-2100-30 1  In 1 CARTON contains a BOTTLE
4 300  In 1 BOTTLE This package is contained within the CARTON (0280-2100-30)
5 0280-2100-40 1  In 1 CARTON contains a BOTTLE
5 400  In 1 BOTTLE This package is contained within the CARTON (0280-2100-40)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 07/12/2022

Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
Revised: 11/2012Bayer HealthCare LLC, Consumer Care