COLACE- docusate sodium capsule

Colace by

Drug Labeling and Warnings

Colace by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Drug Facts

Colace 100 mg

ACTIVE INGREDIENT

Active ingredient (in each capsule):

Docusate sodium 100 mg

PURPOSE

Purpose

Stool softener

INDICATIONS & USAGE

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

WARNINGS AND PRECAUTIONS

Warnings

Do not use

• if you are presently taking mineral oil, unless told to do so by a doctor

ASK DOCTOR/PHARMACIST

Ask a doctor before use if you have

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

DO NOT USE

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

PREGNANCY OR BREAST FEEDING

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

STORAGE AND HANDLING

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 INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

WARNINGS

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

COLACE 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-3319(NDC:67618-101)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/29/2021

Labeler - REMEDYREPACK INC. (829572556)