Label: PEDIA-LAX- glycerin liquid

  • NDC Code(s): 0132-0195-12
  • Packager: C.B. Fleet Company, Inc.
  • 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 17, 2019

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


  • Active ingredient (in each 2.7 mL average delivered dose)

    Glycerin 2.8 g

  • Purpose

    Hyperosmotic laxative

  • Uses

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

    For rectal use only

    May cause rectal discomfort or a burning sensation.

    Ask a doctor before using any laxative if the 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
    • if constipation continues after one week of use, contact your child's doctor

    Stop using this product and consult a doctor if the child has

    • rectal bleeding
    • no bowel movement within 1 hour of 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 (1-800-222-1222) right away.

  • Directions

    Single Daily Dosage (per 24 hours)

    children 2 to under 6 years: one suppository per day or as directed by a doctor

    children under 2 years: consult a doctor

    Administering the laxative:

    CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING. Hold unit upright, grasping bulb of unit with fingers. Grasp orange protective shield with other hand, pull gently to remove. With steady pressure, gently insert tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Discontinue use if resistance is encountered. Forcing the tip can result in injury. Insertion may be easier if child receiving suppository bears down as if having a bowel movement. This helps relax the muscles around the anus. Squeeze the bulb until nearly all liquid is expelled. While continuing to squeeze the bulb, remove tip from rectum and discard unit. It is not necessary to empty unit completely. The unit contains more than the amount of liquid needed for effective use. A small amount of liquid will remain in the unit after squeezing.

    Left-side position: Place child on left side with knees bent and arms resting comfortably.

    Knee-chest position: Have child kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

  • Other information

    carton sealed for safety. If seal with Fleet emblem on bottom flap or top flap is broken or missing, do not use.

  • Inactive ingredients

    edetate disodium, purified water

  • Questions?

    1-866-255-6960 or


    Baby Care

    Pedia-Lax ®

    Liquid glycerin suppositories

    rectal laxative

    6 applicators (4 ml each)


Baby Care

Pedia-Lax ®
Liquid glycerin suppositories
rectal laxative 

6 applicators (4 ml each)

    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0195
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0195-126 in 1 CARTON02/01/2019
    14 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33402/01/2019
    Labeler - C.B. Fleet Company, Inc. (003119054)