COLISTAT - docusate sodium tablet, film coated 
Amvilab LLC

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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Drug Facts

Active ingredient (in each tablet)

Docusate Sodium 100 mg

Purpose

Stool Softener

Uses

Warnings


Do not use

  • laxative products for longer than one week unless directed to do so by a doctor
  • if you are presently taking mineral oil unless told to do so by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed  a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding
  • 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.

Keep out of Reach of Children.

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

Directions

Adults and
children 12 years of age and older:
Take 1 tablet as needed,
not to exceed more than 3
tablets daily, or as directed
by a doctor.
Children under
12 years of age:
Consult a doctor before use.






Other information

Inactive ingredients

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.

Questions?

If you have any questions or comments, or to report an adverse event, please contact +1 404 256 8817

Principal Display Panel

COLISTAT

Docusate Sodium

Stool Softener



50 TABLETS 100 mg each



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COLISTAT 
docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69975-750
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (Round Biconvex with bisect) Size11mm
FlavorImprint Code GPI;S1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69975-750-0550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/16/2015
Labeler - Amvilab LLC (006092439)
Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(69975-750)

Revised: 7/2015
Document Id: 024105d7-d4a4-4370-acfe-854032e043f5
Set id: 87e4f962-08b8-4817-9c31-d8b411f52af3
Version: 1
Effective Time: 20150716
 
Amvilab LLC