Bayer Aspirin

Bayer Aspirin
SPL v13
SPL
SPL Set ID 356e4ff4-a7f1-4a50-9b86-2555e232b300
Route
ORAL
Published
Effective Date 2021-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: BAYER;BAYER Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-24

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • colds
  • minor pain of arthritis
  • temporarily reduces fever

Dosage and Administration

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
Description

Drug Facts

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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or 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
Section 50570-1

Do not use

  • if you are allergic to aspirin or any other any other pain reliever/ fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6

Inactive ingredients

corn starch, hypromellose, powdered cellulose, triacetin

Section 53413-1

Questions? 1-800-331-4536

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.

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Bayer Aspirin Label

Bayer ®

Aspirin ( NSAID) Pain Reliever/Fever Reducer

GENUINE ASPIRIN

The Wonder Drug ®

325 mg

Safe Pain Relief +

Lifesaving Benefits

Talk to your doctor or other healthcare provider

before using this product for your heart.

Push in Tab and Pull

To Open

100 POUCHES OF 2 TABLETS

200 Coated Tablets


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • colds
  • minor pain of arthritis
  • temporarily reduces fever

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or 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
Section 50570-1 (50570-1)

Do not use

  • if you are allergic to aspirin or any other any other pain reliever/ fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)

Inactive ingredients

corn starch, hypromellose, powdered cellulose, triacetin

Section 53413-1 (53413-1)

Questions? 1-800-331-4536

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Bayer Aspirin Label

Bayer ®

Aspirin ( NSAID) Pain Reliever/Fever Reducer

GENUINE ASPIRIN

The Wonder Drug ®

325 mg

Safe Pain Relief +

Lifesaving Benefits

Talk to your doctor or other healthcare provider

before using this product for your heart.

Push in Tab and Pull

To Open

100 POUCHES OF 2 TABLETS

200 Coated Tablets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)