AVEDANA GLYCERIN LAXATIVE- glycerin suppository suppository

Avedana Glycerin by

Drug Labeling and Warnings

Avedana Glycerin by is a Otc medication manufactured, distributed, or labeled by Unipack LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient                                                      Purpose
(in each suppository)
Glycerin, USP 2 grams ............................................Laxative

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 you have

Ask a doctor before use if you have

- abdominal pain - nausea - vomiting - noticed a sudden change in bowel habits that lasts over 2 weeks

When using this product

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

Stop use and ask a doctor if

Stop use and ask a doctor if

-you have rectal bleeding

-you fail to have a bowel movement after use of a laxative

These could be signs of a serious condition.

If pregnant or breast-feeding, 

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

Directions

adults and children 6 years and over                     1 suppository per day or as directed by a doctor
children 2 to under 6 years                                   use Child Suppositories
children under 2 years                                          ask a doctor

-insert 1 suppository well up into the rectum and retain for 15 minutes
-it need not melt to produce laxative action

Other information

-keep tightly closed - avoid excessive heat

Inactive ingredients

purified water, sodium hydroxide, stearic acid

Product Label

INGREDIENTS AND APPEARANCE

AVEDANA GLYCERIN  LAXATIVE
glycerin suppository suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-440
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	83 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)	8.5 g  in 100 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	1.2 g  in 100 g
WATER (UNII: 059QF0KO0R)	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	Marketing Start Date	Marketing End Date
1	NDC: 43749-440-00	250 g in 1 JAR; Type 0: Not a Combination Product	09/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/17/2017

Labeler - Unipack, Inc. (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(43749-440)