Geritrex Aspirin Tablet, Coated
FDA Label NDC 54162-940

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Geritrex Aspirin (NDC 54162-940). 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 asprin 325 mg, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Asprin 325 Mg

Pain Reliever/Fever Reducer
(NSAID)

Active Ingredient (In Each Tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves:

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

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

    • 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]
    • are age 60 or older
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

Do Not Use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If

  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • stomach bleeding warning applies to you
  • 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 right away.
  • 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
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • These could be signs of a serious condition.

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.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3
    tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a
    doctor
  • children under 12 years: do not use unless directed by a doctor

Other Information

  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

corn starch, hypromellose, polyethylene glycol,
propylene glycol

Questions Or Comments?

1-800-736-3437

Package Label.Principal Display Panel

325 mg (Geritrex Asprin 325mg 5416294090)

325 mg (Geritrex Asprin 325mg 5416294090)

* Please review the disclaimer below.