bisac-10 

bisac-10 
SPL v2
SPL
SPL Set ID 10816e1e-b00c-4f6f-a544-278635919d37
Route
rectal
Published
Effective Date 2021-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
deacetylbisacodyl (10 mg)
Inactive Ingredients
polyethylene glycol, unspecified

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-02-15

Purpose

Laxative

Description

Bisacodyl 10 mg


Medication Information

Warnings

For rectal use only

Do not use

• laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

• laxative products for a period longer than 1 week unless directed by a doctor

Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

it may cause • abdominal discomfort • faintness

                     • rectal burning              • mild cramps

                     • store at temperatures not above 86°F (30°C)

Stop use and ask a doctor if

• rectal bleeding

• failure to have a bowel movement which occurs after use of a laxative may indicate a serious condition.

Uses

• for relief of occasional constipation

• this product generally produces bowel movement in 1/4 to 1 hour

Purpose

Laxative

Directions

• adults and children 12 years of age: 1 suppository, once daily

• suppository should be moistened with water before inserting.

Other Information

• store in well closed containers

Inactive Ingredients

polyethylene glycol

Description

Bisacodyl 10 mg

Questions?

You may also report serious side effects to this phone number.

Mon - Sun: 24/7

Section 42229-5

Bisacodyl Stimulant Laxative

Suppositories For Adults

FOR RECTAL USE ONLY

Manufactured by:

Galen Pharmaceuticals Ltd.

334/5 GIDC Estate Waghodia,

Vadodara, Gujarat, India, 391760

Country of Origin: India

Web: www.galenltd.com

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient (in Each Suppository)

Bisacodyl 10 mg


Structured Label Content

Warnings

For rectal use only

Do not use

• laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

• laxative products for a period longer than 1 week unless directed by a doctor

Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

it may cause • abdominal discomfort • faintness

                     • rectal burning              • mild cramps

                     • store at temperatures not above 86°F (30°C)

Stop use and ask a doctor if

• rectal bleeding

• failure to have a bowel movement which occurs after use of a laxative may indicate a serious condition.

Uses

• for relief of occasional constipation

• this product generally produces bowel movement in 1/4 to 1 hour

Purpose

Laxative

Directions

• adults and children 12 years of age: 1 suppository, once daily

• suppository should be moistened with water before inserting.

Other Information (Other information)

• store in well closed containers

Inactive Ingredients (Inactive ingredients)

polyethylene glycol

Questions?

You may also report serious side effects to this phone number.

Mon - Sun: 24/7

Section 42229-5 (42229-5)

Bisacodyl Stimulant Laxative

Suppositories For Adults

FOR RECTAL USE ONLY

Manufactured by:

Galen Pharmaceuticals Ltd.

334/5 GIDC Estate Waghodia,

Vadodara, Gujarat, India, 391760

Country of Origin: India

Web: www.galenltd.com

Section 50565-1 (50565-1)

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

Packaging

Drug Facts

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

Bisacodyl 10 mg


Advanced Ingredient Data


Raw Label Data

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