AVEDANA GLYCERIN LAXATIVE- glycerin suppository 
Unipack, Inc.

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.

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Avedana® Glycerin Suppositories 100 count
Drug Facts

Active Ingredient

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

Uses

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

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

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

Other information

-keep tightly closed - avoid excessive heat

Inactive ingredients

purified water, sodium hydroxide, stearic acid

Product Label

Avedana® Glycerin Suppositories | 100 count in a Jar |

Product Label 100 ct Glycerin Suppositories

AVEDANA GLYCERIN  LAXATIVE
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-440
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (CLEAR) Score    
ShapeBULLETSize32mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-440-00100 in 1 JAR; Type 0: Not a Combination Product09/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/17/2017
Labeler - Unipack, Inc. (009248480)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(43749-440) , label(43749-440)

Revised: 1/2021
Document Id: 027dabc8-10b6-4fca-ae4a-4f1edf7afffc
Set id: 4c1f7ab1-6274-4dd1-bbfc-869dec5797cf
Version: 5
Effective Time: 20210115
 
Unipack, Inc.