DOCUPRENE  - docusate sodium tablet 
Pharmaceutica North America, Inc.

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DOCUPRENE 100mg

Active Ingredient (in each tablet)                              Purpose

Sodium Dioctyl Sulfosuccinate          100mg             Stool Softner 

Each tablet contains 8 mg. of Sodium

Inactive Ingredients

Dicalcium phosphate, microcrystalline cellulose, pregelatinized starch, croscamellose sodium, stearic acid, colloidal silicon dioxide, magnesium sterate, titanium dioxide, talc, hypromellose, polyethylene glycol, FDandC blue #1




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 bowel habits that persists over a period of 2 weeks.  Stop use and ask a doctor if: You have rectal bleeding or if 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  North America Glendale CA

Docuprene


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 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
STEARIC ACID  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
TITANIUM DIOXIDE  
TALC  
HYPROMELLOSES  
POLYETHYLENE GLYCOL  
FD&C BLUE NO. 1  
Product Characteristics
Color blue (Blue) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code none
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 not final part334 06/16/2010

Labeler - Pharmaceutica North America, Inc. (962739699)
Revised: 12/2010 Pharmaceutica North America, Inc.