DOCUPRENE  - docusate sodium tablet 
Pharmaceutica North America, Inc.

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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 NDC Product Code (Source) 45861-201 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 8

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color white (White) Score no score Shape ROUND Size 11mm Flavor Imprint Code CPC513 Contains

Packaging # NDC Package Description Multilevel Packaging 1 45861-201-60 60 TABLET In 1 BOTTLE None

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: 06/2010Pharmaceutica North America, Inc.