Label: HUMCO SENNA LEAVES- senna leaves extract

  • NDC Code(s): 0395-2649-01, 0395-2649-94
  • Packager: Humco Holding Group, 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 December 13, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Senna Leaves

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  • Purpose

    Stimulant laxative

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  • Use

    For the temporary relief of occasional constipation. Bowel movement is generlly produced in 6 to 12 hours.

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  • Warnings

    Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.

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  • Ask a doctor before use

    if you have noticed a sudden change in bowel habits that persits over a period of 2 weeks. Laxative product should not be used for a period of longer than 1 week unless directed by a doctor.

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  • When using this product

    Discontinie use and consult a doctor if you have rectal bleeding or failure to hav a bowel movement after the use of a laxative. These symptoms may indicate a serious condition.

    If pregnant or breast feeding ask a health professional before use.

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  • Keep out of reach of children

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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  • Directions

    Adults and children 12 yrs. of age and older: oral dose is 1 to 3 teaspoonful of tea (prepared as indicated below) once or twice daily or as directed by a doctor.

    not recommended for Children under 12 yrs. of age. Consult a doctor before use.

    Prepare a tea by steeping 1 ounce of rinsed Senna Leaves in one pint boiling water; let stand 1 hour. Then strain. Press out all the liquid and discard leaves.

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  • Inactive Ingredient

    none

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  • Principal display panel
  • INGREDIENTS AND APPEARANCE
    HUMCO SENNA LEAVES 
    senna leaves extract
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-2649
    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 1000 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0395-2649-94 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017
    2 NDC:0395-2649-01 454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    Name Address ID/FEI Business Operations
    Humco Holding Group, Inc 825672884 manufacture(0395-2649) , analysis(0395-2649) , pack(0395-2649) , label(0395-2649)
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