Low Dose Chewable Aspirin

Low Dose Chewable Aspirin
SPL v1
SPL
SPL Set ID 8b2a1a27-ee41-4960-87ee-aaca181ce8d2
Route
ORAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn Dextrates Fd&c Yellow No. 6 Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Imprint: AZ;013 Shape: round Color: orange Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

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

Purpose

Pain reliever 


Medication Information

Purpose

Pain reliever 

Description

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

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor
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 Allert: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 
  • If you have ever had an allergic reaction to this product or any of its ingredients
Other Information
  • store at room temperature
Inactive Ingredients

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium

Questions Or Comments?

Call 1-844-912-4012 Monday through Friday 9 AM - 5 PM EST.

Principal Display Panel

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 help right away
  • you experience any of the following signs of stomach bleeding:

    • feel faint

    • vomit blood

    • have bloody or black stool

    • have stomach pain that does not get better

    • pain gets worse or last mote than 10 days

    • readness or swelling is present

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

Active Ingredient (in Each Tablet)

Aspirin 81 mg (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
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 Allert: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 
  • If you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium

Questions Or Comments? (Questions or comments?)

Call 1-844-912-4012 Monday through Friday 9 AM - 5 PM EST.

Principal Display Panel

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 help right away
  • you experience any of the following signs of stomach bleeding:

    • feel faint

    • vomit blood

    • have bloody or black stool

    • have stomach pain that does not get better

    • pain gets worse or last mote than 10 days

    • readness or swelling is present

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

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

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

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

you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

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