First Aid Direct Chewable Aspirin

First Aid Direct Chewable Aspirin
SPL v6
SPL
SPL Set ID ff6960f6-9f55-4f32-9ab5-9187724531e9
Route
ORAL
Published
Effective Date 2025-09-25
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

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-25

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
  • ask your doctor about other uses for 81mg chewable 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
Section 53414-9

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.

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 
Questions?

1-800-327-2704 M-F 8am - 5pm (CDT)

Other Information
  • store at room temperature
  • Keep out of reach of children 
Inactive Ingredients

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

Principal Display Panel

LOW DOSE ASPIRIN

25 Chewable Tablets

1 Tablet per packet

Pain Reliever

  • Temporary relief of minor aches and pains or as recommended by your doctor

Compare active ingredient to Bayer® Chewable Aspirin

Manufactured for: fad first aid direct Mason, OH 45040

LOW DOSE ASPIRIN

PAIN RELIEVER (NSAID)

Each chewable tablet contains:

Aspirin 81mg (NSAID*)

Stop Use and Ask A Doctor If
  • an allergic reaction occurs. Seek medical help 
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug


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 81mg chewable 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
Section 53414-9 (53414-9)

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.

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 
Questions?

1-800-327-2704 M-F 8am - 5pm (CDT)

Other Information (Other information)
  • store at room temperature
  • Keep out of reach of children 
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

LOW DOSE ASPIRIN

25 Chewable Tablets

1 Tablet per packet

Pain Reliever

  • Temporary relief of minor aches and pains or as recommended by your doctor

Compare active ingredient to Bayer® Chewable Aspirin

Manufactured for: fad first aid direct Mason, OH 45040

LOW DOSE ASPIRIN

PAIN RELIEVER (NSAID)

Each chewable tablet contains:

Aspirin 81mg (NSAID*)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • an allergic reaction occurs. Seek medical help 
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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