Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 859e0fbc-052e-42dd-aa4e-746637ff11f5
Route
ORAL
Published
Effective Date 2021-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn Dextrose Monohydrate Fd&c Yellow No. 6 Silicon Dioxide Saccharin Sodium Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH034 Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2007-08-22

Description

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

Purpose

Pain reliever

How Supplied

Product: 50090-0909 NDC: 50090-0909-0 36 TABLET, CHEWABLE in a BOTTLE


Medication Information

Purpose

Pain reliever

How Supplied

Product: 50090-0909

NDC: 50090-0909-0 36 TABLET, CHEWABLE in a BOTTLE

Description

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

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor
  • ask your doctor about other uses for this product
Aspirin
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.

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
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
Do Not Use
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Questions?

Adverse drug event call: (866) 562-2756 M-F 8AM - 4PM

Other Information
  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature (15°-30°C)
  • avoid excess heat and moisture

Inactive Ingredients

Corn starch, dextrose monohydrate, FD&C yellow #6, flavor, silicon dioxide, sodium saccharine and stearic acid.

Ask A Doctor Before Use If
  • the 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 have asthma
  • you are taking a diuretic

Stop Use and Ask A Doctor If
  • 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
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs
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.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are 

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor
  • ask your doctor about other uses for this product
Aspirin
Purpose

Pain reliever

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.

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
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
Do Not Use (Do not use)
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Questions?

Adverse drug event call: (866) 562-2756 M-F 8AM - 4PM

How Supplied (HOW SUPPLIED)

Product: 50090-0909

NDC: 50090-0909-0 36 TABLET, CHEWABLE in a BOTTLE

Other Information (Other information)
  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature (15°-30°C)
  • avoid excess heat and moisture

Inactive Ingredients (Inactive ingredients)

Corn starch, dextrose monohydrate, FD&C yellow #6, flavor, silicon dioxide, sodium saccharine and stearic acid.

Ask A Doctor Before Use If (Ask a doctor before use if)
  • the 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 have asthma
  • you are taking a diuretic

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs
If Pregnant Or Breast Feeding, (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. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

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

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are  (Ask a doctor or pharmacist before use if you are )

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)