Label: DOCUSATE SODIUM tablet, film coated

  • 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 April 9, 2019

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

  • ACTIVE INGREDIENT

    Sennosides from Senna Concentrate 8.6mg

    Docusate Sodium 50mg

  • PURPOSE

    Laxative

    Stool Softner

  • PURPOSE


    elieves occasional constipation (irregularity)
    generally produces a bowel movement in 6-12 hours

  • WARNINGS

    Do not use

    laxative products for longer than 1 week unless directed by a doctor
    if you are taking mineral oil, unless directed by a doctor

    Ask a doctor before use if you have

    stomach pain
    nausea
    vomiting
    noticed a sudden change in bowel habits that continues over a period of 2 weeks

    Stop use and ask a doctor if

    you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These may indicate a serious condition.

    If pregnant or breast feeding,

    ask a healthcare professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

  • INSTRUCTIONS FOR USE

    take preferably at bedtime or as directed by a doctor

    age

    starting dosage

    maximum dosage

    Adults and children 12 years and over

    2 tablets once a day

    4 tablets twice a day

    Children 6 to under 12 years

    1 tablet once a day

    2 tablets twice a day

    Children 2 to under 6 years

    1/2 tablet once a day

    1 tablet twice a day

    Children under 2 years

    ask a doctor

    ask a doctor

  • STORAGE AND HANDLING

    each tablet contains 10 mg of calcium, sodium 5 mg
    store at 25°(77°F); excursions permitted between 15o-30oC (59o-86oF)

  • INACTIVE INGREDIENT


    crosscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide

  • QUESTIONS


    866) 562-2756 Mon-Fri 8 AM to 4 PM EST

  • DOSAGE & ADMINISTRATION

    Directions:

    Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.

    Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day

    Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day

    Children to2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day

    Children under 2 years - Ask a doctor

  • INDICATIONS & USAGE

    Uses:

    Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours

  • KEEP OUT OF REACH OF CHILDREN


    keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    498-60

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-498(NDC:16103-378)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colororange (ORANGE COLOR) Scoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-498-6060 in 1 BOTTLE; Type 0: Not a Combination Product11/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/05/2018
    Labeler - DIRECTRX (079254320)
    Registrant - DIRECTRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECTRX079254320repack(61919-498)