Label: PEDIA-LAX- glycerin liquid
- NDC Code(s): 0132-0195-12
- Packager: C.B. Fleet Company, Inc.
- 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 January 17, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 2.7 mL average delivered dose)
- Purpose
- Uses
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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
- abdominal pain, nausea or vomiting
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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
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEDIA-LAX
glycerin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0195 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2.8 g in 4 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0195-12 6 in 1 CARTON 02/01/2019 1 4 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 02/01/2019 Labeler - C.B. Fleet Company, Inc. (003119054)
