Avedana ®

Avedana ®
SPL v8
SPL
SPL Set ID e2824884-515a-4a87-bffe-c9d0e97c6c8b
Route
RECTAL
Published
Effective Date 2020-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (10 mg)
Inactive Ingredients
Palm Kernel Oil

Identifiers & Packaging

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

Description

                                                                   Purpose Bisacodyl USP, 10 mg.................................Stimulant Laxative

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

                                                                   Purpose Bisacodyl USP, 10 mg.................................Stimulant Laxative

Uses

Uses - For temporarily relief of occasional constipation and irregularity

-This product generally produces bowel movement in 15 minutes to 1 hour

Label

Avedana ® Bisacodyl Suppositories

Warnings

For rectal use only.

Directions

Adults and children 12 years of age and older              Children 6 to under 12 years                 Children under 6

One suppository once daily                                         1/2 suppository once daily                    Ask doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppository well into the rectum

-Do not use more than once per day

Do Not Use

Do not use - more than once per day - for a period of longer than one week unless directed by a doctor - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask A Doctor

Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks

Other Information

Other information - Store at room temperature: 15 o - 30 oC (59 o - 86 oF). Do not exceed 30 oC (86 oF) - Individually sealed for your protection.  Do not use if foil is torn or open

Inactive Ingredient

Inactive ingredient  Hydrogenated vegetable oil

When Using This Product

When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop Use and Ask A Doctor

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after using a laxative.  This may indicate 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

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Suppository)

                                                                   Purpose

Bisacodyl USP, 10 mg.................................Stimulant Laxative


Structured Label Content

Uses

Uses - For temporarily relief of occasional constipation and irregularity

-This product generally produces bowel movement in 15 minutes to 1 hour

Label

Avedana ® Bisacodyl Suppositories

Purpose

Stimulant Laxative

Warnings

For rectal use only.

Directions

Adults and children 12 years of age and older              Children 6 to under 12 years                 Children under 6

One suppository once daily                                         1/2 suppository once daily                    Ask doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppository well into the rectum

-Do not use more than once per day

Do Not Use (Do not use)

Do not use - more than once per day - for a period of longer than one week unless directed by a doctor - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask A Doctor (Ask a doctor)

Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks

Other Information (Other information)

Other information - Store at room temperature: 15 o - 30 oC (59 o - 86 oF). Do not exceed 30 oC (86 oF) - Individually sealed for your protection.  Do not use if foil is torn or open

Inactive Ingredient (Inactive ingredient)

Inactive ingredient  Hydrogenated vegetable oil

When Using This Product (When using this product)

When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after using a laxative.  This may indicate a serious condition

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

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

Keep Out of Reach of Children (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.

Active Ingredient (in Each Suppository) (Active Ingredient (in each Suppository))

                                                                   Purpose

Bisacodyl USP, 10 mg.................................Stimulant Laxative


Advanced Ingredient Data


Raw Label Data

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