Regular Strength Aspirin Ec
FDA Label NDC 50090-3450

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Regular Strength Aspirin Ec (NDC 50090-3450). 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, purpose, uses, warnings, do not use, ask doctor, ask doctor/pharmacist, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

  • Active ingredient (in each tablet)                  Purpose
  •  Aspirin 325 mg (NSAID*).............................Pain reliever
  •  *nonsteroidal anti-inflammatory drug

Purpose

  •  Purpose
    Pain reliever

Uses

  • Uses
    • ofor the temporary relief of minor aches and pains due to
    •  
      •  
        • ▪headache
        • ▪colds
        • ▪muscle pain
        • ▪menstrual pain
        • ▪toothache
        • ▪minor pain of arthritis
        • oor as directed by your doctor

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 or 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:
    • ohives
    • ofacial swelling
    • oshock
    • oasthma (wheezing)
    •  Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
      • oare age 60 or older
      • ohave had stomach ulcers or bleeding problems
      • otake a blood thinning (anticoagulant) or steroid drug
      • otake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
      • ohave 3 or more alcoholic drinks every day while using this product
      • otake more or for a longer time than directed

Do Not Use

  • Do not use
    • oif you are allergic to aspirin or any other pain reliever/fever reducer

Ask Doctor

  • Ask a doctor before use if
    • ostomach bleeding warning applies to you
    • oyou have a history of stomach problems, such as heartburn
    • oyou have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • oyou are taking a diuretic
    • oyou have asthma
    • oyou have not been drinking fluids

Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you are
    • otaking a prescription drug for diabetes, gout, or arthritis
    • otaking any other drugs
    • ounder a doctor's care for any serious condition

Stop Use

  • Stop use and ask a doctor if
    • oyou experience any of the following signs of stomach bleeding:
    •  
      •  
        • ▪feel faint
        • ▪have bloody or black stools
        • ▪vomit blood
        • ▪have stomach pain that does not get better
        • opain gets worse or lasts more than 10 days
        • ofever gets worse or lasts more than 3 days
        • oredness or swelling is present in the painful area
        • oany new symptoms appear
        • oringing in the ears or a loss of hearing occurs

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.

Directions

  • Directions
    • odrink a full glass of water with each dose
    • oadults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
    • ochildren under 12 years: consult a doctor

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 (1-800-222-1222).

Storage And Handling

  • Other information
    • ostore at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • ouse by expiration date on package

Inactive Ingredients

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

Questions

Questions? To Report Adverse Drug Event Call: (800) 616-2471

How Supplied

Product: 50090-3450

NDC: 50090-3450-1 30 TABLET, DELAYED RELEASE in a BOTTLE

* Please review the disclaimer below.