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 overtake 2-4 tabletsdaily
children 6 to under12 years of agetake 1-2 tabletsdaily
children 2 to under6 years of agetake up to 1 tabletdaily
children under2ask 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 overtake 1-3 capsulesdaily
children 2 to under12 years of agetake 1 capsuledaily
children under2 yearsask 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

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 DrugM00702/08/1957
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 DrugM00701/30/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00705/01/202012/31/2023
Labeler - ATLANTIS CONSUMER HEALTHCARE INC (118983925)
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)

Revised: 12/2023
 
ATLANTIS CONSUMER HEALTHCARE INC