Ascurin
FDA Label NDC 83607-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healthdoc Llc for the product Ascurin (NDC 83607-002). 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 drug facts, active ingredient (per capsule), purpose, use, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient (Per Capsule)

Aspirin (NSAID*) 81mg

Purpose

pain reliever-fever reducer *nonsteriodal anti-inflammatory drug

Use

For the temporary relief of minor aches and pains associated with a cold, headache, toothache, muscular aches, backache, the premenstrual and menstrual periods, for the minor pain from arthritis and to reduce fever

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 have ever had an allergic reaction to 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

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking a prescription drug for diabetes, gout, or 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 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

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.

Directions

  • Adults: Drink a full glass of water with each dose.
  • Adults and children 12 years and over: Take 5-8 capsules every 4 hours not to exceed 49 capsules in 24 hours unless directed by a doctor.
  • Children under 12 years of age: consult a doctor.
  • See your doctor for other uses of aspirin, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Other Information

Do not use the product if the bottle seal inside the bottle lid is broken.

Inactive Ingredients

Curcumin, Hydroxypropyl Methylcellulose, Orange Oil, Polyvinylpyrrolidone.

Questions Or Comments?

Call (609) 902-7128 9:00 AM – 7:00 PM E.T. Monday-Friday

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