Label: DOCUSATE SODIUM WITH SENNOSIDES- docusate sodium 50mg and sennosides 8.6mg 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 August 27, 2020

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

  • 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 not finalpart33411/05/2018
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-958)