037b6805-6722-4ab7-8862-409407a5fea5

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

Warnings

For rectal use only

Uses

-relieves occasional constipation (irregularity)

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

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.

Other Information

-keep tightly closed.

-avoid excessive heat.

Inactive Ingredients

Inactive ingredients

purified water, sodium hydroxide, stearic acid

Description

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

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

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

Warnings

For rectal use only

Uses

-relieves occasional constipation (irregularity)

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

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.

Other Information (Other information)

-keep tightly closed.

-avoid excessive heat.

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

purified water, sodium hydroxide, stearic acid

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

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)