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

Purpose:
Stool softener


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 TypeHUMAN OTC DRUGNDC Product Code (Source)45861-201
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (Blue) Score no score
ShapeROUNDSize11mm
FlavorImprint Code none
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
145861-201-6060 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/16/2010

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