COLISTAT- docusate sodium tablet, film coated

Colistat by

Drug Labeling and Warnings

Colistat by is a Otc medication manufactured, distributed, or labeled by Amvilab LLC, Gemini Pharmaceuticals, Inc. dba Plus Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Docusate Sodium 100 mg

Purpose

Stool Softener

Uses

• for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours.
  

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 andchildren 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 under12 years of age: Consult a doctor before use.

Other information

• Each tablet contains: Calcium 40 mg
• Each tablet contains: Sodium 10  mg
• Store at room temperature.
• Do not use if imprinted safety seal is broken or missing

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

• Gentle
• Effective
• Stimulant Free

50 TABLETS 100 mg each

INGREDIENTS AND APPEARANCE

COLISTAT 
docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69975-750
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	2 pieces
Shape	ROUND (Round Biconvex with bisect)	Size	11mm
Flavor		Imprint Code	GPI;S1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69975-750-05	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/16/2015

Labeler - Amvilab LLC (006092439)

Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma		055942270	manufacture(69975-750)