Walgreens Children Glycerin Laxative: Package Insert and Label Information

WALGREENS CHILDREN GLYCERIN LAXATIVE- glycerin suppository
Walgreens

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.

(in each suppository)
Glycerin, USP 1.2 grams

Uses

-relieves occasional constipation (irregularity)

-generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

Do not use

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if your child have

Ask a doctor before use if your child have

– stomach pain — nausea — vomiting — a sudden change in bowel habits that lasts over 2 weeks

When using this product

When using this product your child may have rectal discomfort or a burning sensation

Stop use and ask a doctor if

Stop use and ask a doctor if your child has rectal bleeding or fail to have a bowel movement after use of a laxative.

These could be signs of a serious condition.

Keep out of reach of children.

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

Directions

children 2 to under 6 years………..carefully insert 1 suppository well into the rectum and retain for 15 minutes; it need not melt to produce laxative action. Do not exceed 1 suppository daily or as directed by a doctor.

children under 2 years………………ask a doctor

Other information

-keep tightly closed

-avoid excessive heat

Inactive ingredients

purified water, sodium hydroxide, stearic acid

Purpose

Laxative

Product Label

WALGREENS CHILDREN GLYCERIN LAXATIVE glycerin suppository suppository

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0440 Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 83 g in 100 g

Inactive Ingredients Ingredient Name Strength STEARIC ACID 8.5 g in 100 g SODIUM HYDROXIDE 1.2 g in 100 g WATER 7.3 g in 100 g

Product Characteristics Color white (CLEAR) Score Shape BULLET Size 32mm Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-0440-25 62.5 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/01/2016

Labeler — Walgreens (008965063)

Establishment
Name	Address	ID/FEI	Operations
Unipack, Inc.		009248480	manufacture (0363-0440)

Revised: 01/2022 Walgreens