Label: GENTLE RELIEF STOOL SOFTNER- gentle relief stool softnet capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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  • Drug Facts

    Gentle Relief Stool Softner

  • Purpose

    Stool Softner

  • Active Ingredient (in each softgel)

    Docusate sodium 100mg

  • 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

    Overdose warning: In case of overdosage, 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 softgel 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
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Inactive ingredients

    • FD&C Red # 40
    • FD&C Yellow # 6
    • Gelatin
    • Glycerin
    • Polyethylene glycol 400
    • Propylene glycol
    • Purified water
    • Sorbitol solution
    • Titanium dioxide
  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

  • Gentle Relief Stool Softner Docusate Sodium 100mg Gentle and Easy Relief of Constipation 24 Softgels Distributed by: Healthlife of USA LLC Rahway NJ 07065 www.healthlifeofusa.com

    Compare to Dulcolax® Stool Softner active ingredients

    image description

  • INGREDIENTS AND APPEARANCE
    GENTLE RELIEF STOOL SOFTNER 
    gentle relief stool softnet capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-124
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-124-241 in 1 CARTON05/31/2017
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/31/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Softech Pharma Pvt. Ltd.677111277manufacture(69517-124) , pack(69517-124)
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