DailyMed - STRATUSCARE BISACODYL- bisacodyl suppository

NDC Code(s): 58980-415-04, 58980-415-08, 58980-415-12, 58980-415-16, view more
58980-415-50
Packager: Stratus Pharmaceuticals

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated April 17, 2025

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient (in each suppository)
Bisacodyl 10mg

Bisacodyl 10mg
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Purpose
Stimulative laxative

Stimulative laxative
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Uses
for relief of occasional constipation and irregularity - this product generally produces bowel movement in 15 minutes to 1 hour
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 15 minutes to 1 hour
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Warning
for rectal use only - 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 ...
for rectal use only
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 before use if you have
- noticed a sudden change in bowel habits that persist over a period of two weeks
When using this product you may have abdominal discomfort, faintness, rectal burning and mild cramps
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition.
If pregnant or breast-feeding, ask a health professional before use.

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

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Directions
Adults and children 12 years of age and olderChildren 6 to under 12 yearsChildren under 6 - One suppository once daily1/2 suppository once dailyAsk a doctor - Detach one suppository from ...
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 a doctor
- Detach one suppository from the strip and remove from foil
- Carefully insert well into rectum
- Do not use more than once per day
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Other information
Store at 15°C to 30°C (59°F to 86°F). Do not exceed 30°C (86°F). Individually sealed for your protection. Do not use if foil is torn or open.
- Store at 15°C to 30°C (59°F to 86°F). Do not exceed 30°C (86°F).
- Individually sealed for your protection. Do not use if foil is torn or open.
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Inactive ingredients
Hydrogenated Vegetable Oil

Hydrogenated Vegetable Oil
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Questions or comments?
1-800-442-7881

1-800-442-7881
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SPL UNCLASSIFIED SECTION
Distributed by: Stratus Pharmaceuticals Inc - 12379 SW 130th Street - Miami, Florida 33186

Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186
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PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box
STRATUSCARE - 12 - Suppositories - Comfort Shaped - Distributed by: STRATUS - PHARMACEUTICALS INC - NDC 58980-415-12 - Gentle Laxative - (BISACODYL USP 10 mg) Stimulant laxative - Gentle yet effective - WORKS IN - 15 ...
STRATUSCARE

12
Suppositories
Comfort Shaped

Distributed by:
STRATUS
PHARMACEUTICALS INC

NDC 58980-415-12

Gentle Laxative
(BISACODYL USP 10 mg)
- Stimulant laxative
- Gentle yet effective
WORKS IN
15 MINUTES
TO 1 HOUR

Compare to the active
ingredient in Dulcolax®*

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Tarmac Products		059890491	MANUFACTURE(58980-415)

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Published Date (What is this?)	Version	Files
Apr 18, 2025	5 (current)	download
Nov 5, 2024	4	download
Nov 3, 2022	3	download
Sep 17, 2019	2	download
May 30, 2014	1	download

Published Date (What is this?)

Version

Files

Apr 18, 2025

5 (current)

download

Nov 5, 2024

download

Nov 3, 2022

download

Sep 17, 2019

download

May 30, 2014

download

	RxCUI	RxNorm NAME	RxTTY
1	198509	bisacodyl 10 MG Rectal Suppository	PSN
2	198509	bisacodyl 10 MG Rectal Suppository	SCD

Label: STRATUSCARE BISACODYL- bisacodyl suppository

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Drug Label Info

Safety

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Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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More Info on this Drug

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 a doctor

	NDC
1	58980-415-04
2	58980-415-08
3	58980-415-12
4	58980-415-16
5	58980-415-50

Label: STRATUSCARE BISACODYL- bisacodyl suppository

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

STRATUSCARE BISACODYL- bisacodyl suppository

Number of versions: 5

STRATUSCARE BISACODYL- bisacodyl suppository

STRATUSCARE BISACODYL- bisacodyl suppository

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STRATUSCARE BISACODYL- bisacodyl suppository

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.