Label: SENNA- sennosides a and b liquid

  • 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 December 31, 2015

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

  • Active Ingredient

    Active ingredient (in each 5 ml) purpose
    Sennosides 8.8 mg …………………………................Laxative

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  • Uses

    relieves occasional constipation (irregularity)
    generally causes bowel movement in 6 to 12 hours

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  • Directions

    shake well before use
    take preferably at bedtime or as directed by a doctor

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  • DOSAGE & ADMINISTRATION

    Age                                                                   Starting Dose                           Maximum Dose
    adults and children                                   12 years 2 - 3 teaspoonfuls         3 teaspoonfuls twice a day
    and older once a day


    6 years to under 12 years of age              1 - 1½ teaspoonfuls once a day       1½ teaspoonfuls twice a day

    2 to under 6 years of age                       ½ - ¾ teaspoon once a day                 ¾ teaspoon once a day

    under 2 years of age consult a doctor consult a doctor

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  • Warnings

    Do Not Use • laxative products for longer than 1 week
    unless directed by a doctor
    Ask a doctor or pharmacist before use if you have
    • stomach pain • nausea • vomiting
    • notice a sudden change in bowel movement that continues
    over a period of 2 weeks
    Stop use and ask a doctor if
    you have rectal bleeding or failure to have a bowel movement
    after use of laxative. These may indicate a serious condition
    If pregnant or breast-feeding, ask a health
    professional before use

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  • Inactive Ingredient

    Flavors, parabens, propylene gylcol, sucrose and water

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  • STORAGE AND HANDLING

    Store at room temperature 15°-30°C (59°-86°F)

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  • KEEP OUT OF REACH OF CHILDREN SECTION

    KEEP OUT OF REACH OF CHILDREN SECTION
    In case of accidental
    overdose, get medical help or contact a Poison Control Center
    immediately

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  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides a and b liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-007
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B 415.36 mg  in 236 mL
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor COFFEE (Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54162-007-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/19/2012
    Labeler - Geritrex LLC (112796248)
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