Active Ingredient (In Each 2.7 Ml Average Delivered Dose)
Glycerin 2.8 g
Pedia-lax Liquid
FDA Label NDC 0132-0195
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Pedia-lax (NDC 0132-0195). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 2.7 ml average delivered dose), purpose, uses, warnings, ask a doctor before using any laxative if the child has, stop using this product and consult a doctor if the child has, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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 Carepedia-lax ®liquid Glycerin Suppositoriesrectal Laxative 6 Applicators (4 mL Each) (Pedia Lax Liquid Glycerin Suppositories 01)
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