COLACE- docusate sodium - sennosides tablet, film coated

Colace by

Drug Labeling and Warnings

Colace by is a Otc medication manufactured, distributed, or labeled by Avrio Health L.P., Purdue Pharma LP, Purdue Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Purpose

Stool softener

Stimulant laxative

INDICATIONS & USAGE

Uses

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

WARNINGS

DO NOT USE

Do not use

• laxative products for longer than 1 week unless told to do so by a doctor
• if you are presently taking mineral oil, unless told to do so by a doctor

ASK 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

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE FORMS & STRENGTHS

Directions

• Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses

• adults and children 12 years and over: take 2-4 tablets daily
• children 6 to under 12 years of age: take 1-2 tablets daily
• children 2 to under 6 years of age: take up to 1 tablet daily
• children under 2: ask a doctor

HOW SUPPLIED

Other information

• each tablet contains: calcium 10 mg, sodium 4 mg VERY LOW SODIUM
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Keep tightly closed.

INACTIVE INGREDIENT

Inactive ingredients

dicalcium phosphate, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide

©2018, Avrio Health L.P.

Mfd. for: Avrio Health L.P.
Stamford, CT 06901-3431

By: Purdue Pharma, 575 Granite Court
Pickering, ON L1W 3W8, Canada

305014-0A

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

Colace 2-In-1
60 Tablet

PRINCIPAL DISPLAY PANEL

Colace 2-In-1
4 Tablets

INGREDIENTS AND APPEARANCE

COLACE 
docusate sodium - sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-110
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED (burgundy)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	P;054
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-110-10	2 in 1 CARTON	02/08/1957
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 67618-110-30	1 in 1 CARTON	02/08/1957
2		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 67618-110-60	1 in 1 CARTON	02/08/1957
3		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	02/08/1957

COLACE 
docusate sodium - sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-121
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED (burgundy)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	P;054
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-121-04	1 in 1 CARTON	02/08/1957
1		4 in 1 BLISTER PACK; 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	02/08/1957

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Purdue Pharma		250955291	MANUFACTURE(67618-110, 67618-121)