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

Dosage and Administration

Uses

- relieves occasional constipation

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

Description

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

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.

Section 55106-9

Active ingredient (in each suppository)                                           Purpose

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

Warning

for rectal use only

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

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)

Inactive Ingredient

hydrogenated vegetable oil

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

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

Dosage and Administration (34068-7)

Uses

- relieves occasional constipation

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

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.

Section 55106-9 (55106-9)

Active ingredient (in each suppository)                                           Purpose

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

Warning

for rectal use only

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

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)

Inactive Ingredient (Inactive ingredient)

hydrogenated vegetable oil

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

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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