Label: DRX CHOICE FIBER THERAPY- methylcellulose tablet

  • NDC Code(s): 68163-122-00
  • 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 caplet)

    Methylcellulose (a non-allergenic fiber) 500mg

  • Purpose

    Bulk-forming 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 over a period of 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

    Take 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.

    Age

    Dose

    Maximum Dose

    adults & children 12 years of age and over

    start with 2 caplets. Increase as needed up to 6 times per day.

    Do not exceed 12 caplets per day

    Children 6-11 years of age

    Start with 1 caplet. Increase as needed up to 6 times per day

    Do not exceed 6 caplets per day

    children under 6 years of age

    Consult a physician

    Consult a physician

  • Other information

    ▪
    each caplet contains: calcium 18 mg
    ▪
    store at room temperature.
    ▪
    protect contents from humidity
    ▪
    keep tightly closed
  • Inactive ingredients

    adipic acid, calcium carbonate, crospovidone, FD&C yellow no. 6 lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, silica.

    Do not use if printed seal under cap is torn or missing.

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    DRx Choice®

    NDC 68163-122-00

    Compare to the active Ingredients in Citrucel® Caplets *

    Methylcellulose

    Fiber Therapy

    NaN
    Gentle and clinically proven effective†

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court,

    East Brunswick, NJ 08816

    †When Used as Directed

    ††Based On Laboratory Testing. Individual Results May Vary.

    *This product is not manufactured or distributed by GlaxoSmithKline, the owner of the registered trademark Citrucel® Caplets.

    DRx Choice fiber therapy methylcellulose 100 Caplets
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE FIBER THERAPY 
    methylcellulose tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-122
    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)500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorORANGE (Light orange) Scoreno score
    ShapeCAPSULE (Caplet) Size19mm
    FlavorImprint Code RP122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-122-00100 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/20/2022
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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