Discount Drug Mart
FDA Label NDC 53943-513

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Discount Drug Mart (NDC 53943-513). 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 tablespoon), purpose, uses:, choking:, allergy alert:, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient: (In Each Tablespoon)

Psyllium husk approximately 3.4 g

Purpose

Fiber Laxative

Uses:

  • effective in treating occasional constipation and regularity.

Choking:

Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Allergy Alert:

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Otc - Ask Doctor

Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea or vomiting

Otc - Stop Use

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

    • These may be signs of a serious condition.

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 at 1-800-222-1222.

Directions:

Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

Adults 12 years & older:

1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily.

6-11 yrs :

½ adult dose in 8 oz of liquid, up to 3 times daily

Under 6 yrs:

Consult a doctor

Laxatives, including bilk fibers, may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

New Users:

Start with 1 dose per day; gradually increased to 3doses per day as necessary.

Other Information:

  • each teaspoon contains: potassium 30 mg; sodium 5 mg
  • PHENYLKETONURICS: CONTAINS PHENYLALANINE,25 mg per teaspoon
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber

Inactive Ingredients:

citric acid, FD&C yellow 6, natural and artificial orange flavor, silica, sucrose.

Principal Display Panel

NDC 53943-513-72

Compare to the Active Ingredient in Metamucil®*

SMOOTH TEXTURE

Natural Fiber

POWDER

Fiber Laxative/Fiber Supplement

100% Natural Psyllium Husk

SUGAR FREE

  • +Relieves Constipation
  • +Restores Regularity

    • Orange Flavor

    48 TABLESPOON DOSES

    NET WT 20.3 oz 1.2 LBS (575 g)

    Fill controlled by weight, not volume

    DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of METAMUCIL®.

    SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DR., MEDINA, OHIO 44256.

    Distributed By:

    Drug Mart-Food Fair

    211 Commerce Dr.

    Medina, Ohio 44256

    Smooth Tesxture Orange Flavor Natural Fiber Powder 48 Tablespoon Doses (51572pvlr)

    Smooth Tesxture Orange Flavor Natural Fiber Powder 48 Tablespoon Doses (51572pvlr)

* Please review the disclaimer below.