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

Warnings

For rectal use only

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

Description

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

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

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

Warnings

For rectal use only

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

-keep tightly closed - avoid excessive heat

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

Avedana ® Glycerin Suppositories | 100 count in a Jar |

Active Ingredient

Active Ingredient                                                      Purpose

(in each suppository)

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

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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