Label: CAREALL SENNOSIDES- sennosides tablet

  • NDC Code(s): 51824-058-01
  • Packager: New World Imports, 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 October 14, 2022

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  • Active Ingredient

    Sennosides

  • Purpose

    Laxative

  • Keep out of Reach of Children

    In case of accidental overdose, contact a doctor or Poison Control Center immediately.

  • Uses

    For relief of occasional constipation and irregularity.

    This product produces a bowel movement in 6 to 12 hours.

  • Warnings

    Do not use laxative products for more than one week unless directed by a doctor

    Ask a doctor before use if you have stomach pains, nausea, vomiting, notice a sudden change in bowel habits that continues over a period of 2 weeks.

    Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative.  These could be signs of a serious condition.

    If Pregnant or breast-feeding ask a health professional before use.

  • Directions

    Take preferably at bedtime or as directed by a doctor.  

    Adults and children over 12 years: 2 tablets once a day.  Maximum of 4 tablets twice a day.

    Children 6 to under 12 years: 1 tablet once a day.  Maximum of 2 tablets twice a day.

    Children 2 to under 6 years: 1/2 tablet once a day.  Maximum of 1 tablet twice a day.

    Children under 2: consult a doctor

  • Inactive Ingredients

    croscarmellose sodium, dibasic dicalcium phosphate, magnesium stearate, microcrystalline cellulose, and silicon dioxide.

  • PRINCIPAL DISPLAY PANEL

    SEN100 Label

  • INGREDIENTS AND APPEARANCE
    CAREALL SENNOSIDES 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-058
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Magnesium stearate (UNII: 70097M6I30)  
    Cellulose, microcrystalline (UNII: OP1R32D61U)  
    Product Characteristics
    Colorbrown (Speckled various shades of brown) Scoreno score
    ShapeROUND (Round) Size8mm
    FlavorImprint Code AZ;217
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-058-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/18/2016
    Labeler - New World Imports, Inc (075372276)
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