Label: PEDIATRIC GLYCERIN LAXATIVE - glycerin suppository 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

If you are a consumer or patient please visit this version.

  • Drug Facts Active ingredient

    (per suppository)

    Glycerin, USP 1 g

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  • Purpose

    Laxative

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  • Keep out of reach of children.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).

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  • Use

    For relief of occasional constipation

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  • Warnings

    For rectal use only. May cause rectal discomfort or burning sensation.

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  • Ask a doctor before use if your child has

    • abdominal pain,nausea,or vomiting.
    • a sudden change in bowel habits lasting more than 2 weeks.
    • if you have already used a laxative for a week
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  • Stop use and ask a doctor if your child has

    rectal bleeding or fails to have a bowel movement within one  hour of using this product.
    This may indicate a serious condition.

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  • If pregnant or breastfeeding,

    ask a doctor before use.

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  • Directions

    • Children 2 to under 6 years:
    • detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows:
    • hold suppository with pointed end up
    • carefully separate tabs with fingernail
    • slowly pull apart by pulling tabs down on both sides
    • remove suppository from wrapper
    • Carefully insert one suppository well into the rectum and retain for 15 minutes
    • It need not melt completely to produce laxative action
    • Generally produces bowel movement in 15 minutes to 1 hour
    • Do not exceed one suppository daily unless directed by a doctor
    • Children under 2 years: consult a doctor
    Acino Leader image1
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  • Inactive ingredients

    sodium stearate, purified water

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  • Other information

    • Store container tightly closed
    • Keep from excessive heat
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  • Pediatric Glycerin Suppository Label

    NDC 49781-080-25

    LEADER®


    Compare to Fleet® active ingredient*

    Pediatric Glycerin Suppositories

    Laxative

    SATISFACTION GUARANTEED

    25 Pediatric Size

    TAMPER-EVIDENT: FOR YOUR SAFETY , SUPPOSITORIES ARE PACKED IN TAMPER-EVIDENT SEALED WRAPPER. DO NOT USE IF WRAPPER IS TORN OR OPEN

    E-Z Open Wrapper

    Distributed by Cardinal Health, Inc.
    Dublin, Ohio 43017
    CIN 4873303
    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.

    This product is not manufactured or distributed by C.B. Fleet Co. Inc., owner of the registered trademark Fleet®. 

    Acino GlySupp 080

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  • INGREDIENTS AND APPEARANCE
    PEDIATRIC GLYCERIN LAXATIVE 
    glycerin suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49781-080
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (GLYCERIN) GLYCERIN 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM STEARATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49781-080-25 25 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 04/01/2014
    Labeler - Cardinal Health, Inc. (097537435)
    Registrant - Acino Products LLC (019385518)
    Establishment
    Name Address ID/FEI Business Operations
    Acino Products LLC 019385518 manufacture(49781-080)
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