Avedana ®

Avedana ®
SPL v8
SPL
SPL Set ID 4c1f7ab1-6274-4dd1-bbfc-869dec5797cf
Route
RECTAL
Published
Effective Date 2021-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (2 g)
Inactive Ingredients
Stearic Acid Sodium Hydroxide Water

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: white Size: 32 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-17

Description

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


Medication Information

Description

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

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
Do Not Use

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

Product Label

Avedana ® Glycerin Suppositories | 100 count in a Jar |

Active Ingredient

Active Ingredient                                                      Purpose

(in each suppository)

Glycerin, USP 2 grams ............................................Laxative

Other Information

-keep tightly closed - avoid excessive heat

Inactive Ingredients

purified water, sodium hydroxide, stearic acid

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.

Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding, 

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

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

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/4 to 1 hour
Warnings

For rectal use only

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
Do Not Use (Do not use)

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

Product Label

Avedana ® Glycerin Suppositories | 100 count in a Jar |

Active Ingredient

Active Ingredient                                                      Purpose

(in each suppository)

Glycerin, USP 2 grams ............................................Laxative

Other Information (Other information)

-keep tightly closed - avoid excessive heat

Inactive Ingredients (Inactive ingredients)

purified water, sodium hydroxide, stearic acid

When Using This Product (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)

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.

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.

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

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

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

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