STRATUSCARE BISACODYL- bisacodyl suppository

Stratuscare Bisacodyl by

Drug Labeling and Warnings

Stratuscare Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Stratus Pharmaceuticals, Tarmac Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each suppository)

Bisacodyl 10mg

Purpose

Stimulative laxative

Uses

• for relief of occasional constipation and irregularity
• this product generally produces bowel movement in 15 minutes to 1 hour

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 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.

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 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

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.

Inactive ingredients

Hydrogenated Vegetable Oil

Questions or comments?

1-800-442-7881

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Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186

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 MINUTES
TO 1 HOUR

Compare to the active
ingredient in Dulcolax®*

INGREDIENTS AND APPEARANCE

STRATUSCARE BISACODYL 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-415
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bisacodyl (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	Bisacodyl	10 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58980-415-04	4 in 1 BOX; Type 0: Not a Combination Product	05/30/2014
2	NDC: 58980-415-08	8 in 1 BOX; Type 0: Not a Combination Product	05/30/2014
3	NDC: 58980-415-12	12 in 1 BOX; Type 0: Not a Combination Product	05/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	05/30/2014

Labeler - Stratus Pharmaceuticals (789001641)

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