COLACE CLEAR- docusate sodium capsule, liquid filled

Colace Clear by

Drug Labeling and Warnings

Colace Clear by is a Otc medication manufactured, distributed, or labeled by Purdue Products LP, Purdue Pharma LP, Catalent Pharma Solutions, LLC, PL Developments. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Colace Clear 50 mg

Active ingredient
(in each soft gel)

Docusate sodium 50 mg

INDICATIONS & USAGE

Purpose

Stool softener

Uses

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

Warnings

Do not use

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

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

QUESTIONS

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.

HOW SUPPLIED

Inactive ingredients

gelatin,glycerin, PEG 400, propylene glycol, sorbitol

Soft gels are imprinted with edible dye-free ink.

©2014, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
Made in the USA
303458-0A

PRINCIPAL DISPLAY PANEL

Colace Clear™ 50 mg Carton
NDC: 67818-100-28

INGREDIENTS AND APPEARANCE

COLACE CLEAR 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-109
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 (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	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	CLR;50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-109-28	1 in 1 CARTON
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	12/16/2014

Labeler - Purdue Products LP (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Pharma Solutions, LLC		051762268	MANUFACTURE(67618-109)

Establishment
Name	Address	ID/FEI	Business Operations
PL Developments		800014821	PACK(67618-109)