Label: GLYCERIN- 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 December 19, 2018

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  • Active ingredient (in each suppository)

    Glycerin 1.2 g

  • Purpose

    Laxative

  • Uses

    • for relief of occasional constipation
    • this product generally produces a bowel movement in 1/4 to 1 hour
  • Warnings

    For rectal use only

    May cause rectal discomfort of burning sensation

    Ask a Doctor before using any laxative if child has

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

    Stop use and consult a doctor if child has

    • rectal bleeding
    • no bowel movement after using this product

    These symptoms may indicate a serious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Single daily dosage

    Children 2 to under 6 years                      1 suppository, or as directed by a doctor

    children under 2 years                              ask a doctor

    Insert suppository well up into rectum.

    Suppository need not melt completely to produce laxative action.

  • Other information

    • Store container tightly closed.
    • Keep away from excessive heat.
  • Inactive ingredients

    purified water, sodium hydroxide, stearic acid

  • Pediatriic Glycerin Suppositories

    The product shown represents a sample of that currently in use. Additional packaging may also be available.

    Pediatric Glycerin Suppositories 30 & 60 per cases. 

    Distributed by:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

    Ped60ct

    Ped30ct

  • INGREDIENTS AND APPEARANCE
    GLYCERIN  
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0222(NDC:46122-222)
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.2 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:17856-0222-230 in 1 BOX, UNIT-DOSE12/19/2018
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:17856-0222-160 in 1 BOX, UNIT-DOSE12/19/2018
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/12/2013
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0222) , repack(17856-0222)
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