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NDC 67618-0372-60 Colace Details

Colace

Colace is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Avrio Health L.P.. The primary component is .

Product Information

NDC	67618-0372
Product ID	67618-372_08b7e432-6c28-4c54-904b-306a80d35718
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Colace
Proprietary Name Suffix	Kit
Non-Proprietary Name	Docusate sodium
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Avrio Health L.P.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 67618-0372-60 (67618037260)

Pricing Information	N/A
NDC Package Code	67618-372-60
Billing NDC	67618037260
Package	1 KIT in 1 KIT (67618-372-60) * 1 BOTTLE, PLASTIC in 1 CARTON (67618-110-30) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (67618-101-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c5c61aa9-1fb2-96d9-f80f-cd6b44f2b2f6 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

SPL UNCLASSIFIED SECTION

Purpose

Stool softener

Stimulant laxative

SPL UNCLASSIFIED SECTION

Uses

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

SPL UNCLASSIFIED SECTION

Warnings

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

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Other information

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

SPL UNCLASSIFIED SECTION

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, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin

Avrio Health L.P.

305608-0A

SPL UNCLASSIFIED SECTION

Colace

Drug Facts

Active ingredient (in each capsule)

Docusate sodium 100 mg

SPL UNCLASSIFIED SECTION

Purpose:

Stool softener

SPL UNCLASSIFIED SECTION

Uses

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

SPL UNCLASSIFIED SECTION

Warnings

Do not use

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

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 capsule daily
children under 2 years	ask a doctor

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

Avrio Health L.P.

304996-0A

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLACE KIT

docusate sodium kit

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description
Packaging
1	NDC:67618-110-30	1 in 1 CARTON
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/08/1957

Part 2 of 2
COLACE docusate sodium capsule

Product Information
Item Code (Source)	NDC:67618-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description
Packaging
1	NDC:67618-101-60	1 in 1 CARTON
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/01/2020

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

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

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Geodis		116937615	PACK(67618-372)

Revised: 5/2021

Document Id: 08b7e432-6c28-4c54-904b-306a80d35718

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

Version: 1

Effective Time: 20210514

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NDC 67618-0372-60 Colace Details

Colace

Product Information

Package

Package Images

NDC 67618-0372-60 (67618037260)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c5c61aa9-1fb2-96d9-f80f-cd6b44f2b2f6 Details

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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