Label: STOOL SOFTENER- docusate sodium 100 mg capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

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 March 9, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)                 Purpose

    Docusate sodium 100 mg..............................Stool softener

  • Uses

    ■ for prevention of dry, hard stools

    ■ for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

  • Warnings

    Do not use

    ■ if you are presently taking mineral oil, unless directed by a doctor

    ■ when abdominal pain, nausea, or vomiting are present

    ■ for longer than 1 week, unless directed by a doctor

    Ask a doctor before use if you have

    noticed a sudden change in bowel habits that continues over a period of 2 weeks

    Stop use and ask a doctor if

    ■ you have rectal bleeding

    ■ you fail to have a bowel movement after use

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ take with a glass of water

    ■ adults and children 12 years of age and over: take 1 to 3 softgels daily. This dose may be taken as single daily dose or in divided doses.

    ■ children 2 to under 12 years of age: take 1 softgels daily

    ■ children under 2 years of age: consult a physician.

  • Other information

    ■ each softgel contains sodium 6 mg

    ■ store at controlled room temperature 15°-30°C (59°-86°F)

    ■ read all product information before using

  • Inactive ingredients

    FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide

  • Questions or comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • PRINCIPAL DISPLAY PANEL

    Compare to the Active Ingredients in Dulcolax® Stool Softener

    STOOL SOFTENER

    Docusate Sodium Softgels, 100 mg

    TO OPEN
    PUSH IN TAB AND PULL OUT

    25 Pouches of 2 Softgels Each

    Principal Display Panel - 50 Pouch Box

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium 100 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-015-2525 in 1 BOX
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70005-015-5050 in 1 BOX
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70005-015-022 in 1 POUCH
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/07/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PVT LTD677385498manufacture(70005-015)
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