COLISTAT PLUS- docusate sodium,sennosides tablet, film coated

Colistat Plus by

Drug Labeling and Warnings

Colistat Plus 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 ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purposes

Docusate Sodium.............................Stool Softener

Sennosides.......................................Laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 6-12 hours
  

Warnings

Do not use

• if you are now taking mineral oil, unless directed by a doctor
  
• laxative products for longer than 1 week unless directed by a doctor
  

Ask a doctor before use if you have

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

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative.

These may indicate a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dose	maximum dose
adults and children 12 years and older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Other information

• Each tablet contains: Calcium 20 mg
• Each tablet contains: Sodium   4 mg
• Store at room temperature
• Keep lid tightly closed in a dry place
  
• Do not use if imprinted seal under cap is broken or missing
• Tamper Evident: Do not use if sealed blister unit is broken or damaged
  

Inactive ingredients

Croscarmellose Sodium, D and C Yellow #10, Dextrose, Dicalcium Phosphate, FD and C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide.

Questions?

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

Principal Display Panel

COLISTAT PLUS

Stool Softener and Stimulant Laxative

• Effective
• Reliable
• Comfortable

60 TABLETS

INGREDIENTS AND APPEARANCE

COLISTAT PLUS 
docusate sodium,sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69975-850
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTROSE (UNII: IY9XDZ35W2)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND (Biconvex)	Size	10mm
Flavor		Imprint Code	G55
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69975-850-06	60 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(69975-850)