FDA Label for Avedana Glycerin Laxative

View Indications, Usage & Precautions

Avedana Glycerin Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Unipack Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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