bisacodyl suppositories

bisacodyl suppositories
SPL v1
SPL
SPL Set ID 6f0aefc9-cd5f-4bdd-89c2-b6a80558987c
Route
rectal
Published
Effective Date 2025-01-24
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
Marketing Status
otc monograph drug active Since 2025-02-01

Description

Active ingredient (in each suppository)                                           Purpose Bisacodyl USP 10 mg.............................................................Stimulant Laxative


Medication Information

Active Ingredient

Active ingredient (in each suppository)                                           Purpose

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

Dosage and Administration

Uses

- relieves occasional constipation

- this product generally produces a bowel movement in 15 minutes 1 hour

Directions

- tear off one suppository from the strip

- peel apart the wrapper

- continue peeling apart to almost the full length of the suppository

- gently remove the suppository from the wrapper

- lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out

- retain it for 15 to 20 minutes

- Do not exceed recommended dose

- if suppository seems soft, place in refrigerator for a short time before use.

 Adults and children 12 years and over  1 suppository once daily
 Children 6 to under 12 years  1/2 suppository once daily
 Children under 6 years     Ask a doctor

Other Information

store at temperatures below 25 oC (77 oF)

Description

Active ingredient (in each suppository)                                           Purpose Bisacodyl USP 10 mg.............................................................Stimulant Laxative

Principal Display Panel

Oncor Pharmaceuticals

NDC 83720-550-25

12 Suppositories

10 mg each

Bisacodyl Suppositories

Fast Acting Smulant Laxative

Manufactured In USA For :

Oncor Pharmaceuticals

6755 Business Pkwy Suite 202

Elkridge, MD 21075

United States.

Rev. 12/24

Section 42228-7

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

Section 42231-1

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

You may report side effects by calling Oncor Pharmaceuticals

(9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this productyou may experience

- rectal burning

- mild cramps

- abdominal discomfort

- faintness

Section 50569-3

Ask a doctor before use if you havea sudden change in bowel habits that lasts over a period od 2 weeks.

Section 55105-1

TAMPER EVIDENT:SUPPOSITORIES ARE WRAPPED IN TAMPER EVIDENT SEALED WRAPPERS. DO NOT USE IF WRAPPER IS TORN OR OPEN WHEN PURCHASED.

Warning

for rectal use only

Do not usewhen abdominal pain, nausea, or vomiting are present.

Inactive Ingredient

hydrogenated vegetable oil

Stop Use and Ask A Doctor If

- you have rectal bleeding or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.

- you need to use a laxative for more than one week


Structured Label Content

Active Ingredient (55106-9)

Active ingredient (in each suppository)                                           Purpose

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

Dosage and Administration (34068-7)

Uses

- relieves occasional constipation

- this product generally produces a bowel movement in 15 minutes 1 hour

Directions

- tear off one suppository from the strip

- peel apart the wrapper

- continue peeling apart to almost the full length of the suppository

- gently remove the suppository from the wrapper

- lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out

- retain it for 15 to 20 minutes

- Do not exceed recommended dose

- if suppository seems soft, place in refrigerator for a short time before use.

 Adults and children 12 years and over  1 suppository once daily
 Children 6 to under 12 years  1/2 suppository once daily
 Children under 6 years     Ask a doctor

Other Information (Other information)

store at temperatures below 25 oC (77 oF)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Oncor Pharmaceuticals

NDC 83720-550-25

12 Suppositories

10 mg each

Bisacodyl Suppositories

Fast Acting Smulant Laxative

Manufactured In USA For :

Oncor Pharmaceuticals

6755 Business Pkwy Suite 202

Elkridge, MD 21075

United States.

Rev. 12/24

Section 42228-7 (42228-7)

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

Section 42231-1 (42231-1)

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

You may report side effects by calling Oncor Pharmaceuticals

(9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this productyou may experience

- rectal burning

- mild cramps

- abdominal discomfort

- faintness

Section 50569-3 (50569-3)

Ask a doctor before use if you havea sudden change in bowel habits that lasts over a period od 2 weeks.

Section 55105-1 (55105-1)

TAMPER EVIDENT:SUPPOSITORIES ARE WRAPPED IN TAMPER EVIDENT SEALED WRAPPERS. DO NOT USE IF WRAPPER IS TORN OR OPEN WHEN PURCHASED.

Warning

for rectal use only

Do not usewhen abdominal pain, nausea, or vomiting are present.

Inactive Ingredient (Inactive ingredient)

hydrogenated vegetable oil

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

- you have rectal bleeding or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.

- you need to use a laxative for more than one week


Advanced Ingredient Data


Raw Label Data

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