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Pill Identifier Information of DOSS Sodium 100 MG Oral Capsule

Drug Information

DOSS Sodium 100 MG Oral Capsule

Imprint: 51A
Shape: C48345
Color: C48326
Ingredients: Docusate
Size: 5.00
Score: 1
Rxtty: SY
Author: Pharbest Pharmaceuticals, Inc.
Inactive Ingredients: D&C Yellow No. 10 / FD&C Red No. 40 / Gelatin / Glycerin / Polyethylene Glycol / Propylene Glycol / Sorbitol>

Complete Information

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg


  • Purpose

    Stool softener

  • Uses

    • prevents/relieves dry hard stool
    • results usually occurs 1 to 3 days after the first dose
  • Warnings


    Do not use
    • when abdominal pain, nausea, or vomiting are present
    • for more than one week unless directed by a doctor

    Ask a doctor before use if you
    • are taking mineral oil
    • have noticed a sudden change in bowel habits that last over 2 weeks

    Stop use and ask a doctor if
    • you have no bowel movement after 3 days
    • you have rectal bleeding
    These could be signs of a serious condition

    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

    • do not exceed recommended dose
    adults and children over 12 years                        
    		take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
    children 6 to 12 years
    		take 1 softgel daily
    children under 6 years
    		consult a doctor
  • Other information

    • Tamper Evident: Do not use if safety seal under cap is broken or missing
    • store at room temperature 15o to 30oC (59o to 86oF)
    • protect from moisture
  • Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.


  • Questions?

    Adverse drug event call: (866) 562-2756

  • Principal Display Panel

    *Compare to the active ingredient of Colace®

    Docusate Sodium

    Stool Softener

    1000 SOFTGELS

    100 mg each

    Image of Docusate label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-384
    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
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (Two-toned- white and clear red) Scoreno score
    ShapeOVALSize5mm
    FlavorImprint Code 51A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-384-08100 in 1 BOTTLE
    2NDC:16103-384-111000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/22/2007
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc557054835repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries Ltd.248441727manufacture
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