COLACE- docusate sodium capsule 
REMEDYREPACK INC.

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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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 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 capsules 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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Colace

GENERIC: Docusate sodium

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-3319-0

COLOR: red

SHAPE: OVAL

SCORE: No score

SIZE: 12 mm

IMPRINT: RPC;053

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

Remedy_Label

COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3319(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:70518-3319-030 in 1 BLISTER PACK; Type 0: Not a Combination Product12/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/29/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2022
Document Id: d4d8da15-be77-95c7-e053-2a95a90a90a1
Set id: 30d23151-3cd8-4a15-a1da-46aa4be8fb79
Version: 1
Effective Time: 20220105
 
REMEDYREPACK INC.