Label: DOCUSATE SODIUM WITH SENNOSIDES- docusate sodium 50mg and sennosides 8.6mg tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 3, 2023

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  • Active Ingredients (in each tablet)

    Sennosides from Senna Concentrate 8.6mg

    Docusate Sodium 50mg

  • Purpose

    Laxative

    Stool Softner

  • Uses

    • relieves 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 right away.(800) 222-1222.

  • Directions

    • 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 daily

    4 tablets twice daily

    Children 6 to under 12 years

    1 tablet once daily

    2 tablets  twice daily

    Children 2 to under 6 years 

    1/2 tablet  once daily

    1 tablet twice daily

    Children under 2 years

    ask a doctor

    ask a  doctor

  • Other information

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

    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 or comments?

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

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Docusate Sodium with Sennosides is a orange, round tablet; Debossed with PH32.

    Bottles of 100 NDC 43063-958-01

    Bottles of 1000 NDC 43063-958-95

    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

  • PRINCIPAL DISPLAY PANEL

    NDC 43063-958-01

    Manufactured in the USA

    *Compare to the active ingredients in Senokot-S ®

    Docusate Sodium 50mg &

    Sennosides 8.6mg

    Natural Vegetable Laxative

    Ingredient Plus Stool Softner

    100 TABLETS

    IMAGE

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM WITH SENNOSIDES 
    docusate sodium 50mg and sennosides 8.6mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-958(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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (ORANGE COLOR) Scoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43063-958-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2019
    2NDC:43063-958-951000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00711/05/2018
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-958)
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