SPL v1
SPL
SPL Set ID 41386de5-5857-efab-e063-6294a90afd9c
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
Titanium Dioxide Croscarmellose Sodium Triethyl Citrate Methacrylic Acid And Ethyl Acrylate Copolymer D&c Yellow No. 10 Fd&c Yellow No. 6 Cellulose, Microcrystalline Talc Stearic Acid Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: I1 Shape: round Color: yellow Size: 4 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
  • For use as directed by a doctor for the prevention of recurrent heart attack or stroke

Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 non-prescription NSAIDs(aspirin, ibuprofen, naproxen, 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°C and 30°C (59°F–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

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
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
  • 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 loss of hearing occurs.
Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

Do Not Use Section

Do not use if:

You are allergic to aspirin or any other pain reliever/fever reducer.

Inactive Ingredients

Microcrystalline Cellulose, Talc, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Titanium Dioxide, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer, D&C Yellow #10, FD&C Yellow #6

Ask A Doctor Before Use
  • Stomach bleeding warning applies to you
  • You have a history of stomach problems, such as heartburn
  • You have a high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You are taking a diuretic
  • You have asthma
Ask A Doctor/pharmacist

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

  • gout
  • diabetes
  • arthritis
Principal Display Panel

NDC 60577-808-01

Vitane's

Aspirin 81mg

Pain Reliever

Aspirin 81 mg (NSAID) Enteric Coated

60 tablets

Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a health professional.

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 (1-800-222-1222) right away.


Structured Label Content

Uses (USES)

  • Temporarily relieves minor aches and pains
  • For use as directed by a doctor for the prevention of recurrent heart attack or stroke

Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 non-prescription NSAIDs(aspirin, ibuprofen, naproxen, 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°C and 30°C (59°F–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)

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)

Allergy Alert:

  • Aspirin may cause a severe allergic reaction which may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
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
  • 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 loss of hearing occurs.
Active Ingredient (ACTIVE INGREDIENT)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

Do Not Use Section (DO NOT USE SECTION)

Do not use if:

You are allergic to aspirin or any other pain reliever/fever reducer.

Inactive Ingredients (INACTIVE INGREDIENTS)

Microcrystalline Cellulose, Talc, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Titanium Dioxide, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer, D&C Yellow #10, FD&C Yellow #6

Ask A Doctor Before Use (ASK A DOCTOR BEFORE USE)
  • Stomach bleeding warning applies to you
  • You have a history of stomach problems, such as heartburn
  • You have a high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You are taking a diuretic
  • You have asthma
Ask A Doctor/pharmacist (ASK A DOCTOR/PHARMACIST)

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

  • gout
  • diabetes
  • arthritis
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 60577-808-01

Vitane's

Aspirin 81mg

Pain Reliever

Aspirin 81 mg (NSAID) Enteric Coated

60 tablets

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

If pregnant or breast-feeding, ask a health professional.

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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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