Label: AVEDANA GLYCERIN LAXATIVE- glycerin suppository

  • 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 November 20, 2021

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  • Active Ingredient

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

  • Uses

    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

    - stomach 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 or 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.

    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                     Insert 1 suppository well into the rectum and retain for 15 minutes; it need not melt to

                                                                              produce laxative action.  Do not exceed 1 suppository daily or as directed by a doctor

    children 2 to under 6 years                                   use Child Suppositories
    children under 2 years                                          ask a doctor

  • Other information

    - keep tightly closed - avoid excessive heat

  • Inactive ingredients

    purified water, sodium hydroxide, stearic acid

  • Avedana ® Glycerin Suppositories | 25 Count in a Jar 

    Product Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    AVEDANA GLYCERIN   LAXATIVE
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-440
    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:43749-440-2525 in 1 JAR; Type 0: Not a Combination Product09/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/18/2014
    Labeler - Unipack, Inc. (009248480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(43749-440) , label(43749-440)
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