Colace by REMEDYREPACK INC.

Drug Details [pdf]

COLACE- docusate sodium capsule
REMEDYREPACK INC.

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Drug Facts

Colace 100 mg

Active ingredient (in each capsule):

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 to do so by a doctor

Ask a doctor before use if you have

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

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

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 over	take 1-3 capsules daily
children 2 to under 12 years of age	take 1 capsules daily
children under 2 years	ask 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

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):

Docusate sodium 100mg in 1

INACTIVE INGREDIENT(S):

D&C RED NO. 33
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SORBITOL
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
TITANIUM DIOXIDE

Remedy_Label

COLACE
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-3319(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 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
Color	red, white	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	RPC;053
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70518-3319-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/29/2021	01/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	12/29/2021	01/05/2022

Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2024

Document Id: 0f3c949e-4b73-d922-e063-6394a90a7d97

Set id: 30d23151-3cd8-4a15-a1da-46aa4be8fb79

Version: 2

Effective Time: 20240118

Trademark Results [Colace]

Mark Image Registration \| Serial	Company Trademark Application Date
COLACE 72001649 0670133 Live/Registered	MEAD JOHNSON & COMPANY 1956-01-30