Label: GLYCERIN LAXATIVE- glycerin based gentle and effective laxative adult constipation relief suppository

  • NDC Code(s): 13709-322-01
  • Packager: NeilMed Pharmaceuticals 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 August 24, 2023

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  • Drug Facts

    Active ingredient (in each suppository)
    Glycerin, USP 2 grams

  • Purpose

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

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in ¼ to 1 hour

  • Warnings

    For rectal use only

  • Do not use

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

  • 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

    you may have rectal discomfort or a burning sensation

  • 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,

    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 of age 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

  • PRINCIPAL DISPLAY PANEL

    Glycerin Suppository

  • INGREDIENTS AND APPEARANCE
    GLYCERIN LAXATIVE 
    glycerin based gentle and effective laxative adult constipation relief suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-322
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-322-0125 in 1 JAR08/24/2023
    11 in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/24/2023
    Labeler - NeilMed Pharmaceuticals Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc.799295915manufacture(13709-322)
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