Drx Choice Fiber Therapy Powder, For Solution
FDA Label NDC 68163-517

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Drx Choice Fiber Therapy (NDC 68163-517). 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 (in each rounded tablespoon), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Rounded Tablespoon)

Methylcellulose (a non-allergenic fiber) 2g

Purpose

Bulk-forming fiber laxative

Uses

  • ▪relieves occasional constipation (irregularity)
  • ▪generally produces a bowel movement in 12-72 hours

Warnings

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.

Ask A Doctor Before Use If You Have

  • ▪a sudden change in bowel habits that persists for two weeks
  • ▪abdominal pain, nausea or vomiting

Stop Use And Ask A Doctor If

  • ▪constipation lasts more than 7 days
  • ▪you have rectal bleeding

    • These could be signs of a serious condition.

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

  • 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
  • use product at the first sign of constipation or irregularity
  • put one dose in a full glass of cold water
  • stir briskly and drink promptly
  • drinking another glass of water is helpful

    • Age

    Dose

    adults & children 12 years of age and over

    start with 1 rounded tablespoon. Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day.

    children 6 - 11 years of age

    start with 2 level teaspoons. Increase as needed, 2 level teaspoons at a time, up to 3 times per day.

    children under 6 years of age

    consult a physician

Other Information

  • each rounded tablespoon contains: calcium 85mg and potassium 125mg
  • each rounded tablespoon contributes 27 calories from maltodextrin
  • store at room temperature
  • protect contents from humidity
  • keep tightly closed

Inactive Ingredients

Anhydrous citric acid, FD&C yellow #6 lake, flavor, maltodextrin, potassium citrate, silica, sucralose, tricalcium phosphate,

Questions Or Comments?

1-866-467-2748

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DRx Choice®

Compare to the Active Ingredient in Citrucel® Powder*

NDC 68163-517-16

Sugar free

Soluble fiber therapy

Methylcellulose Fiber Therapy for Irregularity

  • Gentle and clinically proven effective**
  • Gives you additional fiber to help relieve occasional constipation

    • Fiber for irregularity that won’t cause excess gas***

    Orange Flavor

    Naturally & Artificially Flavored

    NET WT 16.9 OZ (479g)

    Directions for use:

    • 1.Fill glass with at least 8 oz. of cold water.
    • 2.Measure rounded tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

      • **When Used As Directed.

      ***Based On Laboratory Testing. Individual Results may Vary

      TAMPER EVIDENT: DO NOT USE PRINTED INNER SEAL IS BROKEN OR MISSING

      GLUTEN FREE

      *This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Citrucel® Powder.

      Manufactured By:

      Raritan Pharmaceuticals

      8 Joana Court,

      East Brunswick, NJ 08816

      Drx Choice Fiber Therepy Methycellulose (5b594fa0 45d9 4676 A082 7cf767cf30a1 06)

      Drx Choice Fiber Therepy Methycellulose (5b594fa0 45d9 4676 A082 7cf767cf30a1 06)

* Please review the disclaimer below.