COLACE KIT- docusate sodium 
Avrio Health L.P.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Warnings

Do not use

Ask a doctor before use if you have

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.

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

adults and children 12 years and overtake 2-4 tablets daily
children 6 to under 12 years of agetake 1-2 tablets daily
children 2 to under 6 years of agetake up to 1 tablet daily
children under 2ask a doctor

Other information

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

©2020

Avrio Health L.P.

305608-0A

Colace

Drug Facts

Active ingredient (in each capsule)

Docusate sodium 100 mg

Purpose:

Stool softener

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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 overtake 1-3 capsules daily
children 2 to under 12 years of agetake 1 capsule daily
children under 2 yearsask a doctor

Other information

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

Colance Kit

COLACE  KIT
docusate sodium kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-372
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-372-601 in 1 KIT; Type 0: Not a Combination Product05/01/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 30 
Part 21 BOTTLE, PLASTIC 60 
Part 1 of 2
COLACE  
docusate sodium - sennosides tablet, film coated
Product Information
Item Code (Source)NDC:67618-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorRED (burgundy) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code P;054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-110-301 in 1 CARTON
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/08/1957
Part 2 of 2
COLACE 
docusate sodium capsule
Product Information
Item Code (Source)NDC:67618-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorRED, WHITEScoreno score
ShapeOVALSize12mm
FlavorImprint Code RPC;053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-101-601 in 1 CARTON
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/30/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2020
Labeler - Avrio Health L.P. (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation968334974MANUFACTURE(67618-110)
Establishment
NameAddressID/FEIBusiness Operations
P&L Development, LLC079765031PACK(67618-101)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829MANUFACTURE(67618-101)
Establishment
NameAddressID/FEIBusiness Operations
Geodis116937615PACK(67618-372)

Revised: 5/2021
Document Id: 08b7e432-6c28-4c54-904b-306a80d35718
Set id: c5c61aa9-1fb2-96d9-f80f-cd6b44f2b2f6
Version: 1
Effective Time: 20210514
 
Avrio Health L.P.