Xpect Chewable Aspirin Tablet, Chewable
FDA Label NDC 42961-258

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 Corporation for the product Xpect Chewable Aspirin (NDC 42961-258). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Otc - Purpose

Purpose

Pain reliever

Indications & Usage

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 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

Otc - 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

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

Otc - Stop Use

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 lasts more than 10 days 
  • redness or swelling is present 
  • new symptoms occur 
  • ringing in the ears or loss of hearing occurs

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.

Otc - 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.

Dosage & Administration

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 Safety Information

Other information

  • store at room temperature
  • do not use if packet is opened or torn

Inactive Ingredient

Inactive ingredients

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

Otc - Questions

Questions or comments?

Call 1-877-973-2811 Monday – Friday 8 AM – 5 PM

Principal Display Panel - 25 Count Box

Compare to the active ingredient in Bayer® Chewable Aspirin†

CHEWABLE ASPIRIN

Active Ingredient:

Aspirin 

Pain Reliever (NSAID)

Low Dose (81 mg)

Xpect® First aid

25 Tablets / 25 Packets (1 tablet in each packet) per Box

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Aspirin. 

25box (25box)

25box (25box)

* Please review the disclaimer below.