Enteric Coated Aspirin
FDA Label NDC 42254-141

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Enteric Coated Aspirin (NDC 42254-141). 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 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain reliever

Indications & Usage

Uses

temporarily relieves

  • headache
  • muscle pain
  • menstrual pain
  • toothache
  • minor pain of arthritis
  • pain and fever of colds

Warnings

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
  • shock
  • facial swelling
  • asthma (wheezing)
  • Stomach bleeding warning:

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user

    • has had stomach ulcers or bleeding problems
    • takes a blood thinning (anticoagulant) or steroid drug
    • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • takes more or for a longer time than directed
    • has 3 or more alcoholic drinks every day while using this product
    • is age 60 or older

Otc - Do Not Use

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Otc - Ask Doctor

Ask a doctor before use if

  • stomach bleeding warning applies to user
  • user has a history of stomach problems such as heartburn
  • user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • user is taking a diuretic
  • user has asthma
  • user has not been drinking fluids

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if user is

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug
  • under a doctor's care for any serious condition

Otc - Stop Use

Stop use and ask a doctor if

  • user experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • ringing in the ears or a 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 definitely 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 overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and over: 1 - 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Storage And Handling

Other information

  • store at 20° - 25°C (68° - 77°F)

Inactive Ingredient

Inactive ingredients

corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Otc - Questions

Questions or comments?

call

1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

Principal Display Panel

Aspirin Ec 325mg (5gr) (A0f84fac 3f7c 45c0 A2e8 Ce39fb2bd630 01)

Aspirin Ec 325mg (5gr) (A0f84fac 3f7c 45c0 A2e8 Ce39fb2bd630 01)

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