Premier Value Pediatric Glycerin Supp

Premier Value Pediatric Glycerin Supp
SPL v13
SPL
SPL Set ID 022dd494-cb3c-4fa7-be99-4c38fabdc612
Route
RECTAL
Published
Effective Date 2018-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1 g)
Inactive Ingredients
Water Sodium Hydroxide Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-03-21

Description

Glycerin 1 g

Purpose

Hyperosmotic laxative


Medication Information

Purpose

Hyperosmotic laxative

Description

Glycerin 1 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 of burning sensation

Directions

Single daily dosage
children 2 to under 6 years 1 suppository or as directed by a doctor
children under 2 years ask a doctor

Insert suppository well up intorectum.

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 g

Pediatric Glycerin Suppositories, 25 Count

PremVal722.jpg

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

PediatricGlycerin Suppositories, 25 count

Distributed by Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

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 Laxative If Child Has
  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than two 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

Hyperosmotic laxative

Warnings

For rectal use only

May cause rectal discomfort of burning sensation

Directions

Single daily dosage
children 2 to under 6 years 1 suppository or as directed by a doctor
children under 2 years ask a doctor

Insert suppository well up intorectum.

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 g

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

PremVal722.jpg

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

PediatricGlycerin Suppositories, 25 count

Distributed by Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

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 Laxative If Child Has (Ask a Doctor before using laxative if child has)
  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than two weeks
  • already used a laxative for more than 1 week

Advanced Ingredient Data


Raw Label Data

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