DOCUPRENE- docusate sodium tablet 
Pharmaceutica North America, Inc.

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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DOCUPRENE 100mg (Sodium Dioctyl Sulfosuccinate)

ACTIVE INGREDIENT (in each tablet)


Sodium Dioctyl Sulfosuccinate          100mg       

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:

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

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 DRUGItem Code (Source)NDC:45861-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colorblue (Blue) Scoreno score
ShapeROUND (round) Size11mm
FlavorImprint Code C21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45861-201-6060 in 1 BOTTLE; Type 0: Not a Combination Product06/16/201001/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/16/201001/01/2018
Labeler - Pharmaceutica North America, Inc. (962739699)

Revised: 2/2019
 
Pharmaceutica North America, Inc.