Label: ADULT GLYCERIN LAXATIVE  - glycerin suppository 

  • 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 2 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 you have

    • abdominal pain, nausea or vomiting.
    • a sudden change in bowel habits lasting for more than 2 weeks.
    • already used a laxative for more than 1 week.
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  • Stop use and ask a doctor

    if you have rectal bleeding or fail to have a bowel movement after using a laxative.
    This may indicate a serious condition.

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  • If pregnant or breastfeeding,

    ask a doctor before use.

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  • Directions

    Single Daily dosage: 1 suppository or as directed by a doctor

    • Adults and children 6 years and over:
    • detach 1 suppository from the strip; remove the 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
    • insert one suppository well up into the rectum
    • children 2 to 6 years use Leader Pediatric Glycerin Suppositories
    • children under 2 years of age ask a doctor
    Acion Leader image1
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  • Inactive ingredients

    sodium stearate, purified water

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  • Other information

    • This product usually produces a bowel movement in 1/4 to 1 hour
    • Store container tightly closed
    • Keep from excessive heat
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  • Adult Glycerin Suppositories Label

    NDC 49718-081-25

    Leader®

    Compare to Fleet® active ingredient*

    Glycerin Suppositories
    Laxative

    SATISFACTION GUARANTEED

    25 Adult 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, OH 43017  CIN # 4866216
    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®

    Ancino GlySupp 081 Label


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  • INGREDIENTS AND APPEARANCE
    ADULT GLYCERIN LAXATIVE  
    glycerin suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49781-081
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (GLYCERIN) GLYCERIN 2 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM STEARATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49781-081-25 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(49781-081)
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