Aspirin

Aspirin
SPL v6
SPL
SPL Set ID 674e6c61-201d-41de-90f8-4d56099c4e38
Route
ORAL
Published
Effective Date 2020-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Lactose, Unspecified Form Cellulose, Microcrystalline Polysorbate 80 Sodium Hydroxide Talc Titanium Dioxide Triethyl Citrate Ferric Oxide Yellow Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)

Identifiers & Packaging

Pill Appearance
Imprint: 81 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-10

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Warnings and Precautions

Warnings

Purpose

Pain reliever

Description

Drug Facts

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, fever or other symptoms needing immediate relief.
  • ask your doctor about other uses for Aspirin 81 mg
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 50568-5

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

  • gout
  • diabetes
  • arthritis
Section 50570-1

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

Section 51945-4

Compare to the active ingredient in Bayer® Low Dose Aspirin Regimen**



ASPIRIN

ADULT LOW STRENGTH



PAIN RELIEVER

ASPIRIN 81 mg (NSAID)*



120 TABLETS

ENTERIC SAFETY COATED



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.

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
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 0.36 mg
  • store at room temperature
Inactive Ingredients

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

Questions Or Comments?

1-888-333-9792

Stomach Bleeding Warning

This product contains an NSAID, which may cause 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
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 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
Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

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, fever or other symptoms needing immediate relief.
  • ask your doctor about other uses for Aspirin 81 mg
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 50568-5 (50568-5)

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

  • gout
  • diabetes
  • arthritis
Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Compare to the active ingredient in Bayer® Low Dose Aspirin Regimen**



ASPIRIN

ADULT LOW STRENGTH



PAIN RELIEVER

ASPIRIN 81 mg (NSAID)*



120 TABLETS

ENTERIC SAFETY COATED



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.

Purpose

Pain reliever

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
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 0.36 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Stomach Bleeding Warning (Stomach bleeding warning)

This product contains an NSAID, which may cause 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
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 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
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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