Label: DOCUSATE CALCIUM- stool softener capsule, liquid filled

  • NDC Code(s): 57896-424-01
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 30, 2017

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

  • Active ingredient (in each softgel)

    Docusate Calcium 240 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 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.

    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

    • Adults and children 12 years of age and older: take 1 softgel daily, or as recommended by your physician
    • children under 12: consult a doctor
    • do not exceed recommended dose
  • Other information

    • store at room temperature, 15°-30°C (59°-86°F)
    • Package not child resistant
    • Product of USA, Romania or Canada
  • Inactive ingredients

    corn oil, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, sorbitol special, water. May also contain D&C red #33.

  • package Label

    HEALTH STAR

    THE SENSIBLE CHOICE FOR PRICE AND HEALTH

    NDC 57896-424-01

    Docusate Calcium

    Stool Softener

    100 softgels

    240 mg each

    Compare to active ingredient in surfak*

    hst424

  • INGREDIENTS AND APPEARANCE
    DOCUSATE CALCIUM 
    stool softener capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-424
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM240 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    MANNITOL (UNII: 3OWL53L36A)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (capsule) Size18mm
    FlavorImprint Code SCU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-424-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2000
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)