SPL v1
SPL
SPL Set ID 4138d4c0-baa5-1f20-e063-6394a90a788f
Route
ORAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn Stearic Acid Talc Sodium Lauryl Sulfate Titanium Dioxide Triethyl Citrate Triacetin Methacrylic Acid And Ethyl Acrylate Copolymer Hypromellose, Unspecified Cellulose, Microcrystalline D&c Yellow No. 10 Povidone Sodium Bicarbonate Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S;17 Shape: round Color: yellow Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-15

Description

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflamatory drug

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflamatory drug

Uses
  • temporarily relieves minor aches and pains.

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 enteric-coated 81 mg Aspirin.
Section 42229-5

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

Storage
  • store at 25°C (77°F); excursions permitted between 15°and 30°C (59°and 86°F)
  • -use by expiration date on package.
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.

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

- shock

- asthma (wheezing)

Stop Use Section

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, have bloody or black stools, vomit blood, 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 loss of hearing occurs

these could be signs of a serious condition.

Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

Do Not Use Section

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, have bloody or black stools, vomit blood, 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 loss of hearing occurs

these could be signs of a serious condition.

Inactive Ingredient

corn starch, pregelatinized starch, povidone, microcrystalline celulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin.

Ask A Doctor Before Use

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
Principal Display Panel

NDC 60577-807-01

Vitane's

Aspirin 81mg

Pain Reliever -

Aspirin USP 81 mg (NSAID) Enteric Coated

60 tablets

Ask Doctor/pharmacist Section

Ask a doctor or pharmacist before use if you are

- taking a prescription drug for gout, diabetes, or arthritis

- taking any other medication

- under a doctor’s care for any serious condition

Pregnancy Or Breast Feeding Section

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 Section

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Uses (USES)
  • temporarily relieves minor aches and pains.

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 enteric-coated 81 mg Aspirin.
Section 42229-5 (42229-5)

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

Purpose (PURPOSE)

Pain reliever

Storage (STORAGE)
  • store at 25°C (77°F); excursions permitted between 15°and 30°C (59°and 86°F)
  • -use by expiration date on package.
Warnings (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.

Directions (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

- shock

- asthma (wheezing)

Stop Use Section (STOP USE SECTION)

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, have bloody or black stools, vomit blood, 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 loss of hearing occurs

these could be signs of a serious condition.

Active Ingredient (ACTIVE INGREDIENT)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

Do Not Use Section (DO NOT USE SECTION)

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, have bloody or black stools, vomit blood, 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 loss of hearing occurs

these could be signs of a serious condition.

Inactive Ingredient (INACTIVE INGREDIENT)

corn starch, pregelatinized starch, povidone, microcrystalline celulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin.

Ask A Doctor Before Use (ASK A DOCTOR BEFORE USE)

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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 60577-807-01

Vitane's

Aspirin 81mg

Pain Reliever -

Aspirin USP 81 mg (NSAID) Enteric Coated

60 tablets

Ask Doctor/pharmacist Section (ASK DOCTOR/PHARMACIST SECTION)

Ask a doctor or pharmacist before use if you are

- taking a prescription drug for gout, diabetes, or arthritis

- taking any other medication

- under a doctor’s care for any serious condition

Pregnancy Or Breast Feeding Section (PREGNANCY OR BREAST FEEDING SECTION)

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 Section (KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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