Children's Glycerin Suppositories

Children's Glycerin Suppositories
SPL v1
SPL
SPL Set ID 374a2ca3-ee04-09a7-e063-6394a90ab760
Route
RECTAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-11

Description

Glycerin, USP 1 grams

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Glycerin, USP 1 grams

Uses

• relieves occasional constipation (irregularity)

• generally, produces bowel movement in ¼ to 1 hour

Section 51727-6

Purified water, sodium hydroxide, stearic acid

Section 51945-4

Warnings

For rectal use only

Directions
Children 2 to under 6 years 1 suppository per day or as directed by a doctor
Children under 2 years Ask a doctor

Insert 1 suppository well into the rectum. To produce laxative action, suppository is designed to dissolve only partially and may not be noticeable

Do Not Use

laxative products for longer than 1 week unless directed by a doctor

Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Other Information

• Store at room temperature. Do not exceed 30˚ C (86˚ F)

• Lot No. & Exp. Date: see wrapper or box

Questions Or Comments?

1(877) 477-8633

When Using This Product,

your child may have rectal discomfort or a burning sensation

Stop Use and Ask A Doctor If

your child has rectal bleeding or fails 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. (1-800-222-1222)

Ask A Doctor Before Use If You Have

• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks

Active Ingredient(in Each Suppository)

Glycerin, USP 1 grams


Structured Label Content

Uses

• relieves occasional constipation (irregularity)

• generally, produces bowel movement in ¼ to 1 hour

Section 51727-6 (51727-6)

Purified water, sodium hydroxide, stearic acid

Section 51945-4 (51945-4)

Purpose

Laxative

Warnings

For rectal use only

Directions
Children 2 to under 6 years 1 suppository per day or as directed by a doctor
Children under 2 years Ask a doctor

Insert 1 suppository well into the rectum. To produce laxative action, suppository is designed to dissolve only partially and may not be noticeable

Do Not Use (Do not use)

laxative products for longer than 1 week unless directed by a doctor

Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Other Information (Other information)

• Store at room temperature. Do not exceed 30˚ C (86˚ F)

• Lot No. & Exp. Date: see wrapper or box

Questions Or Comments? (Questions or comments?)

1(877) 477-8633

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 fails to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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. (1-800-222-1222)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks

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

Glycerin, USP 1 grams


Advanced Ingredient Data


Raw Label Data

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