PEDIA-LAX- glycerin liquid 
C.B. Fleet Company, Inc.

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.

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Pedia-Lax Liquid Glycerin Suppositories

Active ingredient (in each 2.7 mL average delivered dose)

Glycerin 2.8 g

Purpose

Hyperosmotic laxative

Uses

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 www.pedia-lax.com

PRINCIPAL DISPLAY PANEL 

Baby Care

Pedia-Lax ®

Liquid glycerin suppositories

rectal laxative

6 applicators (4 ml each)

PRINCIPAL DISPLAY PANEL 

Baby Care

Pedia-Lax ®
Liquid glycerin suppositories
rectal laxative 

6 applicators (4 ml each)

PEDIA-LAX 
glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0195
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.8 g  in 4 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#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)

Revised: 1/2019
Document Id: 2db5157b-2ca6-4160-bbf6-8fd37ba8bef5
Set id: ae367381-7146-4307-823d-2bb44c1d4200
Version: 1
Effective Time: 20190117
 
C.B. Fleet Company, Inc.