DOCUSATE CALCIUM (STOOL SOFTENER) CAPSULE, LIQUID FILLED [GERI-CARE PHARMACEUTICAL CORP]

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DOCUSATE CALCIUM (STOOL SOFTENER) CAPSULE, LIQUID FILLED [GERI-CARE PHARMACEUTICAL CORP]
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NDC 57896-424-01
Set ID 4815b9b8-59bd-4af5-924a-f55bc53b9133
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number PART334
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  • 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)
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