First Aid Direct Chewable Aspirin Tablet, Chewable
FDA Label NDC 42961-104

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corp for the product First Aid Direct Chewable Aspirin (NDC 42961-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

pain reliever 

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

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

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 

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

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

  • gout
  • diabetes
  • arthritis

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

Otc - Pregnancy 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.

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.

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
  • Keep out of reach of children 

Inactive Ingredients

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

Questions?

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

Ndc 42961-104-02 - Box

Carton-label.jpg (Carton Label)

Carton-label.jpg (Carton Label)

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

Packet-label.jpg (Packet Label)

Packet-label.jpg (Packet Label)

LOW DOSE ASPIRIN

PAIN RELIEVER (NSAID)

Each chewable tablet contains:

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 81mg chewable aspirin.

1 CHEWABLE TABLET PER PACKET

TAMPER EVIDENT.  DO NOT USE IF PACKET IS OPEN OR TORN. 

* Please review the disclaimer below.