COLACE- docusate sodium capsule, liquid filled

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]

ACTIVE INGREDIENT

Drug Facts

Colace 50 mg

Active ingredients
(in each soft gel)

Docusate sodium 50 mg

PURPOSE

Purpose

Stool softener

INDICATIONS & USAGE

Uses

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

WARNINGS

DO NOT USE

Warnings

Do not use

• 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.
• 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

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 or in divided doses.

• adults and children 12 years and over: take 1-6 soft gels daily
• children 2 to under 12 years of age: take 1-3 soft gels daily
• children under 2 years: ask a doctor

HOW SUPPLIED

Other information

• each soft gel contains: sodium 3 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
gelatin, glycerin, PEG 400, propylene glycol, sorbitol

Soft gels are imprinted with edible dye-free ink.

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

304999-0A

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

Colace 50mg
28 Clear Soft Gels

INGREDIENTS AND APPEARANCE

COLACE 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-111
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
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BROWN (clear to light brown)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	CLR;50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-111-28	1 in 1 CARTON	01/07/1900
1		28 in 1 BOTTLE; 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	01/07/1900

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Softgels Inc.		002193829	MANUFACTURE(67618-111)

Establishment
Name	Address	ID/FEI	Business Operations
P&L Development, LLC		079765031	PACK(67618-111)