Low Dose Aspirin Tablet, Chewable
FDA Label NDC 16103-366

15 label sections · Submitted to the FDA by Pharbest Pharmaceuticals, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc. for the product Low Dose Aspirin (NDC 16103-366). 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, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Aspirin 81mg (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 Chewable Aspirin 81 mg

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

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

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

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

  • 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
  • an allergic reaction occurs. Seek mredical help right away
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

    • These could be signs of a serious condition

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 overdose, get medical help or contact a Poison Control Center right away (800-222-1222).

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

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)

Inactive Ingredients

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

Questions Or Comments?

call 866-562-2756 Mon-Fri 8 AM to 4 PM EST

Package Label.Principal Display Panel

PHARBEST

NDC 16103-366-11

Manufactured in the USA

Aspirin Regimen

Chewable

Aspirin

Low Dose

81mg Pain Reliever (NSAID)

*Compare to the active ingredient in BAYER® Chewable Aspirin

Orange Flavored

1000 TABLETS 

Talk to your doctor or other healthcare provider before using this product for your heart.

* Please review the disclaimer below.