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Vacuant

Stratus Pharmaceuticals, Inc

VACUANT MINI-ENEMA


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

EACH DISPOSABLE TUBE CONTAINS

283mg of Docusate Sodium in a medicinal soft soap base of Polyethylene Glycol and Glycerin.

INDICATIONS

Purpose

For relief of occasional constipation. This product usually produces bowel movement in 2 to 15 minutes.

CONSULT INSERT IN JAR FOR COMPLETE INFORMATION.

WARNINGS

Keep this and all drugs out of reach of children. In case of accidental ingestion or overdose, seek professional assistance or contact a Poison Control Center immediately.

STORAGE

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F).
Protect from Freezing. [See USP Controlled Room Temperature.] Below 50% relative humidity is optimal.

DOSAGE

One unit rectally as needed or as directed by a doctor. Do not exceed doctor's recommendations. See precautions.

ADMINISTRATION

VACUANT™ MINI-ENEMA is to be used as an enema. This is not a suppository. Do not take orally.

DISTRIBUTED BY:
STRATUS PHARMACEUTICALS INC
12379 SW 130TH STREET
MIAMI, FLORIDA 33186

MANUFACTURED BY:
SONAR PRODUCTS. INC., CARLSTADT, NJ 07072

PRINCIPAL DISPLAY PANEL - 30 × 5cc Jar Label

NDC 58980-401-05

\/ACUANT

MINI-ENEMA

30 × 5cc DISPOSABLE TUBES

Stool Softener Evacuant

Distributed by:
STRATUS
PHARMACEUTICALS INC

Vacuant

Vacuant

Docusate Sodium ENEMA

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58980-401
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 283 mg

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
GLYCERIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 TUBE, WITH APPLICATOR
2 NDC:58980-401-05 30 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-01-02


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