Aspirin Pain Reliever

Aspirin Pain Reliever
SPL v5
SPL
SPL Set ID c2759844-a49c-450f-e053-2a95a90a2972
Route
ORAL
Published
Effective Date 2023-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Fd&c Yellow No. 6 Talc Stearic Acid D7 Titanium Dioxide Microcrystalline Cellulose Silicon Dioxide Croscarmellose Sodium Acetyltriethyl Citrate D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: 11 Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-17

Description

Aspirin 81mg (NSAID)

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 81mg (NSAID)

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 or other symptoms needing immediate relief 

• ask your doctor about other uses for Safety Coated 81 mg Aspirin

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
Pregnancy

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.

Warnings:

Reye's syndrome

Children and teenagers who have or are recovering from chickenpox 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.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

Do not use

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

Other Information

• store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients

Microcrystalline Cellulose, Silicon dioxide, Talcum, Cross-carmellose sodium, Steric acid, Colloidal silicon dioxide, Titanium dioxide, Triethyl citrate, Methacrylic acid copolymer, FD&C Yellow#10,FD&C Yellow #6

Questions Or Comments?

Call 1-732-698-5070Monday through Friday, 9 am to 5 pm EST.

Principal Display Panel

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 for 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

Keep Out of Reach of Children

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.

Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID)


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 or other symptoms needing immediate relief 

• ask your doctor about other uses for Safety Coated 81 mg Aspirin

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
Purpose

Pain reliever

Pregnancy (PREGNANCY)

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.

Warnings:

Reye's syndrome

Children and teenagers who have or are recovering from chickenpox 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.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

Do not use

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

Other Information (OTHER INFORMATION)

• store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients (INACTIVE INGREDIENTS)

Microcrystalline Cellulose, Silicon dioxide, Talcum, Cross-carmellose sodium, Steric acid, Colloidal silicon dioxide, Titanium dioxide, Triethyl citrate, Methacrylic acid copolymer, FD&C Yellow#10,FD&C Yellow #6

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-732-698-5070Monday through Friday, 9 am to 5 pm EST.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask A Doctor If (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 for 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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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.

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

Aspirin 81mg (NSAID)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)