COLACE- docusate sodium capsule

Colace by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

Drug Facts

Colace 100 mg

ACTIVE INGREDIENT

Active ingredient (in each capsule):

Docusate sodium 100 mg

PURPOSE

Purpose

Stool softener

INDICATIONS & USAGE

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

WARNINGS AND PRECAUTIONS

Warnings

Do not use

• if you are presently taking mineral oil, unless told to do so by a doctor

ASK DOCTOR/PHARMACIST

Ask a doctor before use if you have

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

DO NOT 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.
• you need to use a stool softener laxative for more than 1 week

PREGNANCY OR BREAST FEEDING

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 only by mouth. Doses may be taken as a single daily dose or in divided doses.

• adults and children 12 years and over: take 1-3 capsules daily
• children 2 to under 12 years of age: take 1 capsules daily
• children under 2 years: ask a doctor

STORAGE AND HANDLING

Other information

• each capsule contains: sodium 5 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

D&C Red No. 33, FD&C Red No. 40,
FD&C Yellow No. 6, gelatin, glycerin, PEG
400, propylene glycol, sorbitol, titanium
dioxide

©2018, Avrio Health L.P.
Dist. by: Avrio Health L.P.
Stamford, CT 06901-3431
304996-0A

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

WARNINGS

PRINCIPAL DISPLAY PANEL

Colace 100 mg 60 Capsules Carton

PRINCIPAL DISPLAY PANEL

Colace 50 mg 30 Capsules Carton

INGREDIENTS AND APPEARANCE

COLACE 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-100
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

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	1mm
Flavor		Imprint Code	RPC;052
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-100-30	1 in 1 CARTON	01/30/1997	08/31/2016
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 67618-100-60	1 in 1 CARTON	01/30/1997
2		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	01/30/1997	08/31/2016

COLACE 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-101
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	1mm
Flavor		Imprint Code	RPC;053
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-101-10	1 in 1 CARTON	01/30/1997
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 67618-101-30	1 in 1 CARTON	01/30/1997
2		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 67618-101-60	1 in 1 CARTON	01/30/1997
3		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 67618-101-52	250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/30/1997

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Pharma Solutions, LLC		051762268	MANUFACTURE(67618-101, 67618-100)

Establishment
Name	Address	ID/FEI	Business Operations
P&L Development, LLC		079765031	PACK(67618-100, 67618-101)