Label: DOCUSATE CALCIUM capsule, liquid filled

  • 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 March 22, 2016

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  • Active ingredient (in each softgel)

    Docusate Calcium 240 mg

    Purpose

    Stool softener

  • Uses

    for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

  • Warnings

    Do not use

    • if  you are currently taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea, or vomiting are present
    • for longer than 1 week, unless directed by a doctor

    Ask a doctor before use if

    you notice a sudden change in bowel habits that persists over a period of 2 weeks.

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use

    These could be signs of s serious condition.

    If pregnant or breast-feeding,

    ask a health care 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 over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor
    • children under 12 years of age: take as directed by a doctor
  • Other information

    • store between 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    corn oil, D&C red #33, edible white ink, FD&C red #40, gelatin, glycerin, purified water and sorbitol special.

  • Questions or comments?

    1-800-645-2158

  • Principal Display Panel

    Compare to active ingredient in SURFAK®*

    Safe, Effective, Non-Habit Forming

    Stool Softener Laxative DC

    Docusate Calcium USP, 240 mg

    SOFTGEL CAPSULES

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *Rugby Laboratories is not affiliated with the owner of the trademark Surfak®.

    Distributed by: Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI  48150

    www.rugbylaboratories.com

  • PRINCIPAL DISPLAY PANEL - 240 mg Capsule Bottle Label

    CommUnityCare Federally Qualified Health Centers

    DOCUSATE
    CALCIUM
    240 MG
    CAPS

    Date:

    Name:
    Dr.

    TAKE 1 CAPSULE BY MOUTH DAILY AS DIRECTED.

    123456

    1/1/01

    DOCUSATE CA.240MG CAPS#30NDC 76413-307-30

    Batch: 123456
    Lot: 123456
    Exp: 1/1/01
    MAJOR

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    PRINCIPAL DISPLAY PANEL - 240 mg Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOCUSATE CALCIUM 
    docusate calcium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-307(NDC:0536-3755)
    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
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorRED (RED) Scoreno score
    ShapeOVAL (OVAL) Size8mm
    FlavorImprint Code P58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76413-307-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33412/01/2011
    Labeler - Central Texas Community Health Centers (079674019)
    Registrant - P and L Development of New York Corporation (800014821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK(76413-307) , RELABEL(76413-307)
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