SPL v1
SPL
SPL Set ID 037b6805-6722-4ab7-8862-409407a5fea5
Route
RECTAL
Published
Effective Date 2014-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (83 g)
Inactive Ingredients
Stearic Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-10-06

Description

Active Ingredient                                                           Purpose (in each suppository)                                                            Glycerin, USP 1.2 g........................................................Laxative


Medication Information

Description

Active Ingredient                                                           Purpose (in each suppository)                                                            Glycerin, USP 1.2 g........................................................Laxative

Uses

-relieves occasional constipation (irregularity)

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

Warnings

For rectal use only

Directions

children 2 to under 6 years                                    1 suppository, or as directed by doctor

children under 2 years                                            ask a doctor

Insert suppository well up into rectum.

Suppository need not melt completely to produce laxative action.

Do Not Use

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

Product Label

Active Ingredient

Active Ingredient                                                           Purpose

(in each suppository)                                                           

Glycerin, USP 1.2 g........................................................Laxative

Other Information

-keep tightly closed.

-avoid 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.

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.

When Using This Product Your Child

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

Ask A Doctor Before Use If Your Child Has

Ask a doctor before use if your child has

- stomach pain      -nausea         -vomiting

- a sudden change in bowel habits lasting more than 2 weeks


Structured Label Content

Uses

-relieves occasional constipation (irregularity)

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

Warnings

For rectal use only

Directions

children 2 to under 6 years                                    1 suppository, or as directed by doctor

children under 2 years                                            ask a doctor

Insert suppository well up into rectum.

Suppository need not melt completely to produce laxative action.

Do Not Use (Do not use)

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

Product Label

Active Ingredient

Active Ingredient                                                           Purpose

(in each suppository)                                                           

Glycerin, USP 1.2 g........................................................Laxative

Other Information (Other information)

-keep tightly closed.

-avoid excessive heat.

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

purified water, sodium hydroxide, stearic acid

Keep Out of Reach of Children. (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.

Stop Use and Ask A Doctor If  (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.

When Using This Product Your Child (When using this product your child)

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

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

Ask a doctor before use if your child has

- stomach pain      -nausea         -vomiting

- a sudden change in bowel habits lasting more than 2 weeks


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)