Label: SUNMARK FIBER LAXATIVE- methylcellulose tablet

  • NDC Code(s): 49348-541-10
  • Packager: Strategic Sourcing Services LLC
  • 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 January 6, 2022

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  • Active ingredient (in each caplet)

    Methylcellulose 500 mg

  • Purpose

    Bulk-forming laxative


  • Uses

    • relieves occasional constipation to help restore and maintain regularity 
    • 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

    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits that persists over a period of 2 weeks

    When using this product

    • do not use laxative products for a period longer than one week unless directed by a doctor
    • do not use if you are on a low salt diet unless directed by a doctor

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • you fail to have a bowel movement after use

    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.

  • Directions

    This product generally produces effect in 12-72 hours

    • take this product (child or adult) dose with atleast 8 ounces (a full glass) of water or other fluid
    • taking this product without enough liquid may cause choking, see choking warning
    AgeDose                       Maximum Dose     
    adults and children 12 years & over               2 capletsup to 6 times daily
    children 6 to 11 years   1 capletup to 6 times daily
    children under 6 years   ask a doctorask a doctor      

  • Other information

    • each caplet contains: sodium 10 mg
    • store below 25oC (77oF)
    • protect contents from moisture
    • keep tightly closed
  • Inactive ingredients

    citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate

  • Principal Display Panel

    sunmark

    COMPARE TO CITRUCEL® CAPLETS ACTIVE INGREDIENT*

    fiber laxative

    Bulk-Forming Laxative

    Daily source of 100% soluble fiber

    METHYLCELLULOSE 500 mg

    THE FIBER WITH NO EXCESS GAS

    100 CAPLETS

    image description

  • INGREDIENTS AND APPEARANCE
    SUNMARK FIBER LAXATIVE  
    methylcellulose tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-541
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 CPS) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 CPS)500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULE (Caplet) Size19mm
    FlavorImprint Code G188
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-541-10100 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/26/2019
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(49348-541)
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