Docuprene Tablets

Generic Name: docusate sodium
Dosage Form: tablet

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.

DOCUPRENE

Active Ingredient (in each tablet)                              Purpose

Sodium Dioctyl Sulfosuccinate          100mg             Stool Softner 

Each tablet contains 8 mg. of Sodium

Inactive Ingredients

Croscamellose Sodium, Dicalcium Phosphate, Magnesium Silicate, Magnesium Stearatem Microcrystalline Cellulose, Pharmceutical Glaze, Silica, Sodium Benzoate and Stearic Acid.

Uses:

For the prevention of dry hard stools

For relief of occasional constipation

This product generally produces bowel movement with 12 to 72 hours.


Warnings

Do not use laxative products for longer that one week unless directed to do so by a doctor and if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have: Abdominal pain, nausea, vomiting, noticed a sudden change in or you fail to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding , ask a doctor before use.

Other Information  

Store at room temperature 68- 77 degrees F

For Questions or Comments

Please email: info pnarx.com

or Call: 877-329-2592

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Adults and children 12 years of age and older: Take 1 or 2 tablets daily

Children Under 12 years of age: Do not use, Consult a doctor before use.

NDC 45861-0201-60  

DOCUPRENE

100 mg

Sodium Dioctyl Sulfosuccinate

60 Tablets

Made in USA

Patent Pending

Manufactured For

Pharmaceutica America Glendale CA

DOCUPRENE 
docusate sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45861-201
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM
Product Characteristics
Color white (White) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code CPC513
Contains         
Packaging
# Item Code Package Description
1 NDC:45861-201-60 60 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part334 06/16/2010
Labeler - Pharmaceutica North America, Inc. (962739699)
Establishment
Name Address ID/FEI Operations
Contract Pharmacal Corporation 057795122 manufacture
Revised: 06/2010
 
Pharmaceutica North America, Inc.



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