Enteric Coated Aspirin Tablet, Delayed Release
FDA Label NDC 70677-1122

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Enteric Coated Aspirin (NDC 70677-1122). 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 other, active ingredient (in each tablet), purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Active Ingredient (In Each Tablet)

Aspirin 325 mg (NSAID)*  

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • colds
    • minor pain of arthritis
    • or as recommended by your doctor

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 more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Otc - Do Not Use

Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

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 aretaking a prescription drug for:

  • diabetes
  • gout
  • 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
    • pain gets worse or lasts for more than 10 days
    • redness or swelling is present
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • 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.

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 (1-800-222-1222).

Directions

  • drink a full glass of water with each dose
  • adults 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
  • children under 12 years: ask a doctor

Other Information

  • store between 20-25°C (68-77°F) in a dry place
  • retain carton for complete product information and warnings

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 Or Comments?

Call 833-358-6431 Monday to Friday 9 am to 7 pm EST

Principal Display Panel

NDC 70677-1122-1

COMPARE TO ECOTRIN® REGULAR STRENGTH ASPIRIN ACTIVE INGREDIENT**

Foster & Thrive™

REGULAR STRENGTH

Enteric Coated Aspirin

325 mg, PAIN RELIEVER (NSAID)

Safety Coated

ACTUAL SIZE

125 TABLETS

Image Description (F1081b02fst R0)

Image Description (F1081b02fst R0)

* Please review the disclaimer below.