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

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69975-850-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Amvilab LLC (006092439)

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

Name	Address	ID/FEI	Business Operations
Establishment
Gemini Pharmaceuticals, Inc. dba Plus Pharma		055942270	manufacture(69975-850)

Drug Facts