Label: 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 January 12, 2011

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  • Active Ingredient (in each suppository)

    Glycerin, USP 2.1 grams

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)

    • generally produces bowel movement in 1 ⁄ 4 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

    • abdominal 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

    • 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,

    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 a doctor

    children 2 to under 6 years

    use pediatric glycerin suppositories

    children under 2 years

    ask a doctor

    • insert 1 suppository well up into rectum and retain for 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

  • PRINCIPAL DISPLAY PANEL

    NDC 37205-320-63
    LEADER®

    Glycerin Suppositories
    LAXATIVE

    Compare to Fleet® active ingredient*

    SATISFACTION GUARANTEED

    Tamper Evident. Do not use if printed inner seal is broken or missing.

    25 Adult Size

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    CIN 1390723
    www.myleader.com
    1-800-200-6313

    All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

    *Fleet® is a registered trademark of C.B. Fleet Co., Inc.

    19-10126LR3C

    Label
  • INGREDIENTS AND APPEARANCE
    GLYCERIN LAXATIVE  
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-320
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2.1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-320-6325 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/03/2002
    Labeler - Cardinal Health (097537435)
    Registrant - G & W Laboratories, Inc. (001271188)
    Establishment
    NameAddressID/FEIBusiness Operations
    G & W Laboratories, Inc.001271188MANUFACTURE(37205-320)
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