Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

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

Drug Label Information

Updated October 23, 2023

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  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool Softener Laxative

  • Uses

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

    Ask a doctor before use if you

    • have stomach pain, nausea or vomiting

    • have a sudden change in bowel habits that lasts longer than 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.

    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 only by mouth.
    Adults and children 12
    years of age and older     		1 to 3 capsules daily.
    May be taken as a single
    daily dose or in divided doses.
    Children 2 to under 12
    years of age     		1 capsule daily
    Children under 2 yearsAsk a doctor

  • Other information

    • each softgel contains: sodium 7 mg. very low sodium

    • store at 59°-77°F (15°-25°C)

    • keep tightly closed

    • product of Romania

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

  • Inactive ingredients

    gelatin, glycerin, PEG, purified water, sorbitol special. Contains less that 1% of D&C red #33, edible ink, FD&C red #40, FD&C yellow #6 (sunset yellow), titanium dioxide

  • Package Label

    1

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-407
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Colorred ((Two-toned- white and clear red)) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-407-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/01/2020
    Labeler - KROGER COMPANY (006999528)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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