Label: SENNA- sennosides tablet

  • 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 October 30, 2017

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  • Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • 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

    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 use of a laxative. These may indicate a serious condition.

    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 preferably at bedtime or as directed by a doctor
     a ge
    		 starting dosage
    		 maximum dosage
     adults and children 12 years of age or older
    		 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
  • Other information

    • each tablet contains: calcium 25 mg, sodium 2mg (very low sodium)
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, , magnesium stearate, microcrystalline cellulose, mineral oil

  • Questions or comments?

    call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Principal Display Panel

    NDC: 17714-122-01

    Senna 8.6mg

    senna 8.6mg

  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-122-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/01/2017
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Laboratories, Inc.037052099manufacture(17714-122)
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