Quality Choice Pediatric Glycerin Supp

Quality Choice Pediatric Glycerin Supp
SPL v2
SPL
SPL Set ID 3386fada-6b7f-46fd-e063-6294a90abffc
Route
RECTAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1.2 g)
Inactive Ingredients
Sodium Hydroxide Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-24

Description

Glycerin 1.2 g

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Glycerin 1.2 g

Uses
  • for relief of occasional constipation
  • this product generally produces a 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

childrien 2 to under 6-1 suppository, or as directed by a doctor

children under 2 years-ask a doctor

Insert suppository well up into rectum.

Suppository need not melt completely to produce laxative action.

Other Information
  • Store container tightly closed.
  • Keep away from excessive heat.

Inactive Ingredients

purified water, sodium hydroxide, stearic acid

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Suppository)

Glycerin 1.2 g

Pediatric Glycerin Suppositories, 25 Count

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

PediatricGlycerin Suppositories, 25 count

Distributed by C.D.M.A. Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

QC Pediatric25ct.jpg

Stop Use and Consult A Doctor If Child Has
  • rectal bleeding
  • no bowel movement within 1 hour of using this product

These symptoms may indicate a serious condition.

Ask A Doctor Before Using Any Laxative If 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


Structured Label Content

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

Purpose

Laxative

Warnings

For rectal use only

May cause rectal discomfort or a burning sensation

Directions

Single daily dosage

childrien 2 to under 6-1 suppository, or as directed by a doctor

children under 2 years-ask a doctor

Insert suppository well up into rectum.

Suppository need not melt completely to produce laxative action.

Other Information (Other information)
  • Store container tightly closed.
  • Keep away from excessive heat.

Inactive Ingredients (Inactive ingredients)

purified water, sodium hydroxide, stearic acid

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

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Suppository) (Active ingredient (in each suppository))

Glycerin 1.2 g

Pediatric Glycerin Suppositories, 25 Count (Pediatric Glycerin Suppositories, 25 count)

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

PediatricGlycerin Suppositories, 25 count

Distributed by C.D.M.A. Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

QC Pediatric25ct.jpg

Stop Use and Consult A Doctor If Child Has (Stop use and consult a doctor if child has)
  • rectal bleeding
  • no bowel movement within 1 hour of using this product

These symptoms may indicate a serious condition.

Ask A Doctor Before Using Any Laxative If Child Has (Ask a Doctor before using any laxative if 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


Advanced Ingredient Data


Raw Label Data

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