Colace by ATLANTIS CONSUMER HEALTHCARE INC / Purdue Pharma LP / Contract Pharmacal Corporation / P&L Development, LLC / Patheon Softgels Inc. Colace 2-in-1

Colace by

Drug Labeling and Warnings

Colace by is a Otc medication manufactured, distributed, or labeled by ATLANTIS CONSUMER HEALTHCARE INC, Purdue Pharma LP, Contract Pharmacal Corporation, P&L Development, LLC, Patheon Softgels Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLACE KIT- docusate sodium 
ATLANTIS CONSUMER HEALTHCARE INC

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Colace 2-in-1

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

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

Warnings

Do not use

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

Ask a doctor beforeuse if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over2 weeks

Stop use andask a doctor if you have rectal bleeding or fail to have abowel movement after use of a laxative. These could be signs of aserious condition.

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

Keep out ofreach of children. In case of overdose, get medical help orcontact a Poison Control Center right away.

Directions

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

• adults and children12 years and over: take 2-4 tabletsdaily
• children 6 to under12 years of age: take 1-2 tabletsdaily
• children 2 to under6 years of age: take up to 1 tabletdaily
• children under2: ask a doctor

Other information

• each tablet contains: calcium 7 mg, sodium 4 mg VERYLOW SODIUM
• store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F).

Inactive ingredients

Croscarmellose sodium,dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake,FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin,microcrystalline cellulose, mineral oil, polyethylene glycol, sodiumbenzoate, sodium lauryl sulfate, starch, stearic acid, talc, titaniumdioxide, triacetin

©2020

Avrio HealthL.P.

305608-0A

Colace

Drug Facts

Active ingredient (in eachcapsule)

Docusate sodium 100 mg

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 todo so by a doctor

Ask a doctor beforeuse if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over2 weeks

Stop use andask a doctor if

• you have rectal bleeding or fail to have a bowel movementafter use of a laxative. These could be signs of a serious condition
• you need to use a stool softener laxative for more than1 week

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

Keep out of reachof children. In case of overdose, get medical help or contacta Poison Control Center right away.

Directions: Take only by mouth. Doses may be taken as a single dailydose or in divided doses.

• adults and children12 years and over: take 1-3 capsulesdaily
• children 2 to under12 years of age: take 1 capsuledaily
• children under2 years: ask a doctor

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 ingredients

D&C Red No. 33, FD&C Blue #1, FD&C Red No. 40,
FD&C Yellow No. 6, gelatin, glycerin, PEG
400, propylene glycol, sorbitol, titanium
dioxide

©2018,

Avrio Health L.P.

304996-0A

COLACE  KIT
docusate sodium kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-372

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-372-60	1 in 1 KIT; Type 0: Not a Combination Product	05/01/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	30
Part 2	1 BOTTLE, PLASTIC	60

Part 1 of 2

COLACE 
docusate sodium - sennosides tablet, film coated

Product Information
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

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: 67618-110-30	1 in 1 CARTON
1		30 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 Drug	M007	02/08/1957

Part 2 of 2

COLACE 
docusate sodium capsule

Product Information
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 BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED, WHITE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	RPC;053
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-101-60	1 in 1 CARTON
1		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 Drug	M007	01/30/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	05/01/2020	12/31/2023

Labeler - ATLANTIS CONSUMER HEALTHCARE INC (118983925)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		968334974	MANUFACTURE(67618-110)

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

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Softgels Inc.		002193829	MANUFACTURE(67618-101)

Revised: 12/2023

Document Id: 1a28ceb0-db46-48e1-916c-578e8d82298a

34390-5

Set id: c5c61aa9-1fb2-96d9-f80f-cd6b44f2b2f6

Version: 2

Effective Time: 20231222