Bayer®

Bayer®
SPL v2
SPL
SPL Set ID 84ce59f0-5cb4-4ba4-81f3-020676deb31e
Route
ORAL
Published
Effective Date 2014-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Hypromelloses Sodium Carbonate Zinc Stearate

Identifiers & Packaging

Pill Appearance
Imprint: BA;325 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 1995-02-27

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily relieves

  • headache
  • menstrual pain
  • minor pain of arthritis
  • muscle pain
  • pain and fever of colds
  • toothache
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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
Section 50568-5

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

  • gout
  • diabetes
  • arthritis
Section 50569-3

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
  • you have a sodium-restricted diet
Section 50570-1

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Section 53414-9

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.

Purposes

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

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
  • each tablet contains: sodium 47 mg
  • store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use.
  • save carton for full directions and warnings
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, sodium carbonate, zinc stearate

Questions Or Comments?

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

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
Active Ingredient (in Each Tablet)

Aspirin 325 mg (NSAID)

nonsteroidal anti-inflammatory drug

Principal Display Panel 325 Mg Tablet

SEE NEW WARNINGS INFORMATION

NEW!

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

REGULAR

STRENGTH

325 mg

FAST, SAFE PAIN RELIEF


Structured Label Content

Uses

temporarily relieves

  • headache
  • menstrual pain
  • minor pain of arthritis
  • muscle pain
  • pain and fever of colds
  • toothache
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50568-5 (50568-5)

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

  • gout
  • diabetes
  • arthritis
Section 50569-3 (50569-3)

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
  • you have a sodium-restricted diet
Section 50570-1 (50570-1)

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Section 53414-9 (53414-9)

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.

Purposes

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 (Other information)
  • each tablet contains: sodium 47 mg
  • store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use.
  • save carton for full directions and warnings
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, hypromellose, sodium carbonate, zinc stearate

Questions Or Comments? (Questions or comments?)

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

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

Aspirin 325 mg (NSAID)

nonsteroidal anti-inflammatory drug

Principal Display Panel 325 Mg Tablet (PRINCIPAL DISPLAY PANEL - 325 mg Tablet)

SEE NEW WARNINGS INFORMATION

NEW!

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

REGULAR

STRENGTH

325 mg

FAST, SAFE PAIN RELIEF


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)