Label: LEADER GLYCERIN LAXATIVE- glycerin suppository

  • NDC Code(s): 70000-0450-1
  • Packager: Cardinal Health, 110 dba LEADER
  • 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 19, 2022

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  • Active Ingredient

    Active Ingredient                                                      Purpose
    (in each suppository)
    Glycerin, USP 2 grams ............................................Laxative

  • Uses

    relieves occasional constipation (irregularity)

    generally produces bowel movement in 1/4 to 1 hour

  • Warnings

    For rectal use only

  • Do not use

    Do not use laxative products for longer than 1 week unless directed by a doctor

  • Ask a doctor before use if you have

    Ask a doctor before use if you have

    - abdominal pain - nausea - vomiting - noticed a sudden change in bowel habits that lasts over 2 weeks

  • When using this product

    When using this product you may have rectal discomfort or a burning sensation

  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    -you have rectal bleeding

    -you fail to have a bowel movement after use of a laxative

    These could be signs of a serious condition.

  • If pregnant or breast-feeding, 

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

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 6 years and over                     1 suppository per day or as directed by doctor
    children 2 to under 6 years                                   use CVS/pharmacy(TM) Child Suppositories
    children under 2 years                                          ask a doctor

    insert 1 suppository well up into the rectum and retain fo 15 minutes
    it need not melt to produce laxative action

  • Other information

    keep tightly closed - avoid excessive heat

  • Inactive ingredients

    purified water, sodium hydroxide, stearic acid

  • Product Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    LEADER GLYCERIN   LAXATIVE
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0450
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (CLEAR) Score    
    ShapeBULLETSize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0450-125 in 1 JAR; Type 0: Not a Combination Product01/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/18/2014
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(70000-0450)
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