Label: STOOL SOFTENER  - docusate sodium capsule, liquid filled 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

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  • Purpose

    Stool Softener Laxative

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  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
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  • Warnings

    Ask a doctor before use if you

    • have stomach pain, nausea or vomiting

    • have a sudden change in bowel habits that persists over a period of 2 weeks

    • are presently taking mineral oil

    Stop use and ask a doctor if

    • you need to use a laxative longer than 1 week

    • you have rectal bleeding or fail to have a bowel movement. These

    could be signs of a serious condition.

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

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

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  • Directions

    • adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

    • children under 12: consult a doctor

    • do not exceed recommended dose

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  • Other information

    • sodium 5 mg. very low sodium each softgel contains:

    • store at 15°C-25°C(59° F-77° F)

    • keep tightly closed

    • product from USA or Canada

    • Do not use if imprinted seal under cap is missing or broken. Tamper Evident:

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  • Inactive ingredients

    FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.

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  • STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED
  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER  
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50436-1223(NDC:57896-401)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    PROPYLENE GLYCOL  
    SORBITOL  
    WATER  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    MANNITOL  
    Product Characteristics
    Color red (reddish) Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code SCU1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50436-1223-1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 01/01/2000
    Labeler - Unit Dose Services (831995316)
    Registrant - Unit Dose Services (831995316)
    Establishment
    Name Address ID/FEI Business Operations
    Unit Dose Services 831995316 REPACK(50436-1223)
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