VACUANT PLUS- docusate sodium and benzocaine enema 
Stratus Pharmaceuticals

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.

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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

Principal Display Panel - 30 x 5cc Jar Label
VACUANT PLUS 
docusate sodium and benzocaine enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-402
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium283 mg  in 5 mL
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-402-0530 in 1 JAR01/02/201201/01/2014
15 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/02/201201/01/2014
Labeler - Stratus Pharmaceuticals (789001641)

Revised: 10/2017
Document Id: 6c9fd950-c94c-48d4-ba9f-484e3d8a7fd5
Set id: 819fb434-2596-4e22-9551-3d2efc891c86
Version: 2
Effective Time: 20171027
 
Stratus Pharmaceuticals