Label: DOCUSATE SODIUM AND SENNA- docusate sodium and senna tablet, film coated

  • NDC Code(s): 0536-0355-01, 0536-0355-10
  • Packager: Rugby Laboratories, Inc
  • 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 September 22, 2011

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

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Docusate Sodium 50 mg
    Sennosides 8.6 mg
  • PURPOSE

    Purposes
    Stool Softener
    Stimulant Laxative
  • INDICATIONS & USAGE

    Uses
    • relieves occasional constipation
    • generally produces bowel movement in 6-12 hours
  • WARNINGS

    Warnings
  • DO NOT USE

    Do not use
    • for longer than one week
    • if you are taking mineral oil
    • when abdominal pain, nausea or vomiting are present
  • ASK DOCTOR

    Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
  • STOP USE

    Stop use and ask a doctor if
    • you have rectal bleeding
    • you fail to have a bowel movement after use of this product.
    These may indicate a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 years and over: 2-4 tablets once daily or in divided doses
    children 6 to under 12 years: 1-2 tablets once daily or in divided doses
    children 2 to under 6 years: 1/2-1 tablet once daily or in divided doses
    children under 2 years: ask a doctor
  • STORAGE AND HANDLING

    Other information
    • each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
    • store at 20°-25°C (68°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD-C blue #2 aluminum lake, FD-C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), sodium benzoate, stearic acid, titanium dioxide
  • QUESTIONS

    Questions or comments?
    call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
  • PRINCIPAL DISPLAY PANEL


    BOTTLE LABEL

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM AND SENNA  
    docusate sodium and senna tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0355
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpurple (burgundy) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL;131
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-0355-01100 in 1 BOX
    2NDC:0536-0355-101000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/22/2011
    Labeler - Rugby Laboratories, Inc (109178264)
    Registrant - Time Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Labs, Inc037052099manufacture