Label: SENNA-LAX- sennosides tablet

  • NDC Code(s): 53041-159-14, 53041-159-16
  • Packager: Guardian Drug Company
  • 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 January 13, 2022

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  • Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    relieves: occasional constipation (irregularity)

  • WARNINGS

    Do not use

    • laxative products for longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • abdominal 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 immediately.

  • Directions

    • take preferably at bedtime
    • expect results in 6-12 hours
    • adults and children 12 years and over do not exceed 8 tablets in 24 hours
    • children 6 to under 12 years do not exceed 4 tablets in 24 hours
    • children 2 to under 6 years do not exceed 2 tablets in 24 hours
    • do not exceed the maximum dosage of this product
     adults and children 12 years and over2 tablets once daily (maximum: 4 tablets twice a day) 
     children 6 to under 12 years 1 tablet once daily (maximum: 2 tablets twice a day)
     children 2 to under 6 years 1/2 tablet once daily (maximum: 1 tablet twice a day)
     childrem under 2 years ask a doctor

  • Other information

    • do not use if printed seal under cap is torn or missing
    • store at room temperature
    • avoid excessive humidity
  • Inactive ingredients

    crospovidone, dextrose, magnesium stearate, microcrystalline cellulose, pregelatinized starch

  • PDP

    Compare to the active ingredient in SENOKOT®

    Senna-Lax

    Natural Vegetable Laxative

    Sennosides / Laxative

    For Gentle, Overnight

    Relief of Constipation

    100 Tablets

    Box

  • INGREDIENTS AND APPEARANCE
    SENNA-LAX 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-159
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorbrown (light brown to brown) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code G159
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-159-141 in 1 CARTON02/02/2002
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:53041-159-161 in 1 CARTON02/02/2002
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/02/2002
    Labeler - Guardian Drug Company (119210276)
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