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Vacuant

Dosage form: enema
Ingredients: Docusate Sodium 283mg in 5mL
Labeler: Stratus Pharmaceuticals, Inc
NDC Code: 58980-401

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

VACUANT
MINI-ENEMA

EACH DISPOSABLE TUBE CONTAINS

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

INDICATIONS

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 
docusate sodium enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-401
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (Docusate) Docusate Sodium283 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:58980-401-0530 TUBE, WITH APPLICATOR (TUBE) in 1 JAR
15 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/02/2011
Labeler - Stratus Pharmaceuticals, Inc (789001641)
Establishment
NameAddressID/FEIOperations
Sonar Products Inc104283945MANUFACTURE(58980-401)

Revised: 01/2012
Document Id: e13a0c9c-f829-4f47-bf48-1fa828f20873
Set id: 4bf0dd8c-d071-4860-868f-bb114d7ff6d3
Version: 2
Effective Time: 20120111
 
Stratus Pharmaceuticals, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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