Bayer Genuine Aspirin Aspirin Tablet

Bayer Genuine Aspirin Aspirin Tablet
SPL v10
SPL
SPL Set ID d17834d7-cb3e-6bf2-e053-2a95a90ae5c1
Route
ORAL
Published
Effective Date 2023-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Triacetin Powdered Cellulose Hypromelloses Starch, Corn Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: BAYER Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-08-25 Until 2025-12-31

Description

Aspirin 325 mg (NSAID) 1 nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Aspirin 325 mg (NSAID) 1 nonsteroidal anti-inflammatory drug

Uses

temporarily relieves

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • pain and fever of colds
  • minor pain of arthritis
Directions
  • 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
Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
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.

Other Information
  • save carton for full directions and warnings
  • store at room temperature
Inactive Ingredients

carnauba wax

corn starch, hypromellose, powdered cellulose, triacetin

Questions Or Comments?

1-800-331-4536

(Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

Principal Display Panel

GENUINE ASPIRIN

BAYER®

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

THE WONDER DRUG®

325mg

Safe Pain Relief Plus

Lifesaving Benefits

4 Coated Tablets

Bayer Cvp 4 Count Carton

BAYER ® [Bayer cross]

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

GENUINE ASPIRIN

the wonder drug ®

SAFE PAIN RELIEF +

LIFESAVING BENEFITS

325

mg

[tablets image]

ACTUAL SIZE

Talk to your doctor or other

healthcare provider before using

this product for your heart.

4

Coated

Tablets

CVP

HEALTH

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
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
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center

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.

Active Ingredient (in Each Tablet)

Aspirin 325 mg (NSAID)

1 nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Uses (USES)

temporarily relieves

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • pain and fever of colds
  • minor pain of arthritis
Purpose

Pain reliever/fever reducer

Directions
  • 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
Allergy Alert (Allergy alert)

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Reye's Syndrome (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.

Other Information
  • save carton for full directions and warnings
  • store at room temperature
Inactive Ingredients

carnauba wax

corn starch, hypromellose, powdered cellulose, triacetin

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-331-4536

(Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

GENUINE ASPIRIN

BAYER®

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

THE WONDER DRUG®

325mg

Safe Pain Relief Plus

Lifesaving Benefits

4 Coated Tablets

Bayer Cvp 4 Count Carton (Bayer CVP 4 Count Carton)

BAYER ® [Bayer cross]

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

GENUINE ASPIRIN

the wonder drug ®

SAFE PAIN RELIEF +

LIFESAVING BENEFITS

325

mg

[tablets image]

ACTUAL SIZE

Talk to your doctor or other

healthcare provider before using

this product for your heart.

4

Coated

Tablets

CVP

HEALTH

Stomach Bleeding Warning (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 (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
Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center

If Pregnant Or Breast Feeding, (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.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Aspirin 325 mg (NSAID)

1 nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)