Label: DRX CHOICE FIBER THERAPY- methylcellulose powder, for solution

  • NDC Code(s): 68163-517-16
  • Packager: RARITAN PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 2, 2023

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  • 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

  • Principal Display Panel

    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
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE FIBER THERAPY 
    methylcellulose powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-517
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 MPA.S) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 MPA.S)2 g  in 10.2 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-517-16479 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/18/2022
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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