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Pill Identifier Information of DOSS Sodium 100 MG Oral Capsule

Drug Information

DOSS Sodium 100 MG Oral Capsule

Imprint: DO4
Shape: C48345
Color: C48326
Ingredients: Docusate
Size: 10.00
Score: 1
Rxtty: SY
Author: SPIRIT PHARMACEUTICALS,LLC
Inactive Ingredients: POLYETHYLENE GLYCOL 400 / GLYCERIN / GELATIN / SORBITOL / WATER / D&C RED No. 33 / FD&C RED No. 40 / FD&C Yellow No. 6>

Complete Information

  • Warnings

    Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 2 weeks

    • Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week

    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. Doses may be taken as a single daily dose or in divided doses.
    adults and children 12 years and overtake 1-3 capsules daily
    children 2 to under 12 years of agetake 1 capsule daily
    children under 2 yearsask a doctor
  • Inactive ingredients

    D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, PEG 400, propylene glycol, propylparaben, sorbitol, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    Docusate Sodium capsules USP 100mg

    Each Softgel Contains:
    (Docusate Sodium USP 100mg)

    LOT NO:QUANTITY:
    DRUM NO:NDC NO: 68210-0401-*
    MFG DATE:EXP DATE:

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPERATURE OF 59° – 86°F (15° – 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
    THE F.D & C.ACT AND REGULATIONS THEREUNDER.

    MANUFACTURED BY:
    SOFTGEL HEALTHCARE PVT LIMITED
    INDIA
    LABELLER CODE             : 35916
    LIC NO.                              : TN/DRUGS/00002124

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000
    FAX.# 215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    • 1 - 10
    • 2 - 30
    • 3 - 100
    • 4 - 1000
    • 5 - 16000
    • 6 - 20000
    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0401
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED No. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code DO4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0401-110 in 1 BOX
    2NDC:68210-0401-230 in 1 BOX
    3NDC:68210-0401-3100 in 1 BOX
    4NDC:68210-0401-41000 in 1 BOX
    5NDC:68210-0401-516000 in 1 BOX
    6NDC:68210-0401-620000 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PVT LTD675584180MANUFACTURE