COLACE- docusate sodium capsule 
Atlantis Consumer Healthcare, Inc.

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Drug Facts

Colace 100 mg

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 caseof overdose, get medical help or contact a Poison Control Center rightaway.



Directions: Take only by mouth. Dosesmay be taken as a single daily dose or in divided doses.

adults and children 12 yearsand overtake 1-3 capsules daily
children 2 to under 12 yearsof agetake 1 capsules daily
children under 2 yearsask a doctor

Otherinformation

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

Avrio Health L.P.

304996-0A

Colace 100mg 100 Capsules Carton

305995-0B
COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem 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 RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize12mm
FlavorImprint Code RPC;053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-101-102 in 1 CARTON01/30/1997
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:67618-101-301 in 1 CARTON01/30/1997
230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:67618-101-601 in 1 CARTON01/30/1997
360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:67618-101-011 in 1 CARTON01/17/2022
4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:67618-101-52250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/30/1997
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 12/2023
Document Id: 6e0bf6e9-7a93-4f26-b1cb-9cc9af3b8945
Set id: 7793fced-e8ee-44e2-b212-dd2a59a5f462
Version: 12
Effective Time: 20231226
 
Atlantis Consumer Healthcare, Inc.