Label: SENNA NATURAL RELIEF 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 August 10, 2020

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  • Active Ingredient

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • Uses:

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

  • Warnings:

    Do not use -

    Laxative products for longer than 1 week, unless directed by a doctor.

    If you have ever had an allergic reaction to this product or any of its ingredients.

  • Ask Doctor:

    Ask a doctor before use if you have - Stomach pain, nausea, vomiting, a sudden change in bowel movements that persists over 2 weeks

  • ASK DOCTOR/PHARMACIST:

    Stop use and ask a doctor if you have:

    Rectal bleeding or fail to have a bowel movement after use of a laxative.

    These could be signs of a serious condition.

  • PREGNANCY

    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 (1-800-222-1222), Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DIRECTIONS

    Take preferably at bedtime or as directed by a doctor.

    Dosage

  • OTHER INFORMATION

    store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F)

    each tablet contains: Calcium 25 mg & sodium 3 mg

  • INACTIVE INGREDIENTS

    Colloidal silicon dioxide,croscarmellose sodium, Dicalcium phosphate, Hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, Maltodextrin, Purified water, Sodium lauryl sulphate, Stearic Acid.

  • QUESTIONS OR COMMENTS?

    Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    SENNA NATURAL RELIEF 
    senna natural relief tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID D7 (UNII: T3B081197X)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-031-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/03/2020
    Labeler - Pioneer Life Sciences, LLC (014092742)
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