Vacuant Plus

Dosage form: enema
Ingredients: Docusate Sodium 283mg in 5mL, Benzocaine 20mg in 5mL
Labeler: Stratus Pharmaceuticals
NDC Code: 58980-402

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 Plus
MINI-ENEMA

EACH DISPOSABLE TUBE CONTAINS:

283mg of Docusate Sodium and 20mg of Benzocaine 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.

See bottom of jar and tube crimp for Lot Number and Expiration Date.

DOSAGE

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

ADMINISTRATION

VACUANT™ MINI-ENEMA & VACUANT™ PLUS 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 x 5cc Jar Label

NDC 58980-402-05

VACUANT Plus

MINI-ENEMA

30 x 5cc DISPOSABLE TUBES

Stool Softener Evacuant

Distributed by:
STRATUS
PHARMACEUTICALS INC

VACUANT PLUS 
docusate sodium and benzocaine enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-402
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (Docusate) Docusate Sodium283 mg  in 5 mL
Benzocaine (Benzocaine) Benzocaine20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:58980-402-0530 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 FINALpart33401/02/2012
Labeler - Stratus Pharmaceuticals (789001641)
Establishment
NameAddressID/FEIOperations
Sonar Products Inc104283945MANUFACTURE(58980-402)

Revised: 01/2012
 
Stratus Pharmaceuticals

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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