Pedia-lax Liquid Glycerin Suppositories

Pedia-lax Liquid Glycerin Suppositories
SPL v2
SPL
SPL Set ID ae367381-7146-4307-823d-2bb44c1d4200
Route
RECTAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (2.8 g)
Inactive Ingredients
Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-01

Description

Glycerin 2.8 g

Purpose

Hyperosmotic laxative


Medication Information

Purpose

Hyperosmotic laxative

Description

Glycerin 2.8 g

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.

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.

Questions?

1-866-255-6960 or www.pedia-lax.com

Ask A Doctor
  • 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
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

Principal Display Panel

Baby Care

Pedia -Lax ®

Liquid glycerin suppositories

rectal laxative

6 applicators (4 ml each)

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each 2.7 Ml Average Delivered Dose)

Glycerin 2.8 g

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.


Structured Label Content

Uses
  • for relief of occasional constipation

  • this product generally produces bowel movement in 1/4 to 1 hour
Purpose

Hyperosmotic laxative

Warnings

For rectal use only

May cause rectal discomfort or a burning sensation.

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.

Questions?

1-866-255-6960 or www.pedia-lax.com

Ask A Doctor (Ask a doctor)
  • 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
Other Information (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 (Inactive ingredients)

edetate disodium, purified water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Baby Care

Pedia -Lax ®

Liquid glycerin suppositories

rectal laxative

6 applicators (4 ml each)

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each 2.7 Ml Average Delivered Dose) (Active ingredient (in each 2.7 mL average delivered dose))

Glycerin 2.8 g

Stop Using This Product and Consult A Doctor If the Child Has (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.


Advanced Ingredient Data


Raw Label Data

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