EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]

EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]
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NDC 52327-011-10, 52327-011-11
Set ID 050c6139-344b-47d4-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Aidapak Services, LLC
Generic Name
Product Class
Product Number
Application Number PART334
  • ACTIVE INGREDIENT

    Active Ingredient (in each softgel)

    Docusate Sodium 250 mg

  • PURPOSE

    Purpose

    Stool Softener

  • INDICATIONS & USAGE

    Uses:

    •for the prevention of dry, hard stools

    •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 more than 1 week, unless directed by a doctor.

  • ASK 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 a serious condition.

  • PREGNANCY OR BREAST FEEDING

    •ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

  • INFORMATION FOR PATIENTS

    Directions:

    Adults and children 12 years of age and over:

    take 1 softgel daily or as directed by a doctor.

    Children under 12 years of age: take as directed by doctor.

    Other Information:

    each softgel contains: sodium 15 mg.

    Store between 15-30 C (59-86 F)

  • INACTIVE INGREDIENT

    edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

  • PRINCIPAL DISPLAY PANEL

    UD Blister

    Box Label

  • DOSAGE & ADMINISTRATION

  • KEEP OUT OF REACH OF CHILDREN

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52327-011(NDC:0536-3757)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg  in 250 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code P20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52327-011-11100 in 1 BLISTER PACK10/20/2014
    1NDC:52327-011-101 mg in 1 BLISTER PACK
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/20/2014
    Labeler - Aidapak Services, LLC (831612457)
    Registrant - Aidapak Services, LLC (831612457)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidapak Services, LLC831612457relabel(52327-011)

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