STOOL SOFTENER DOCUSATE SODIUM- docusate sodium capsule, gelatin coated

Stool Softener Docusate Sodium by

Drug Labeling and Warnings

Stool Softener Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MHL NDC:

54257-902-06

Stool Softener
Docusate Sodium 100mg

Compare to the active ingredient in Colace ®*

Effective, Gentle
Stimulant Free
For Comfortable Relief

1000 SOFTGELS

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Active ingredient (in each softgel)

Docusate sodium 100mg

Purpose

Stool softener

Uses

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

Warnings

​Do not use

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

​Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel movements that continues over a period of 2 weeks

​Stop use and ask a doctor if

• you have rectal bleeding or you 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 for mroe than 1 week.

​If pregnant or breast-feeding, ​ask a health professional before use.

​

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center ( ​1-800-222-1222​) right away.

Directions

• Take only by mouth. This dose may be taken as a single daily dose or in divided doses.
• ​adults and children over 12 years of age: ​take 1-3 softgels daily or as directed by a doctor
• ​children 2 to under 12 years of age:​ take 1 softgel daily or as directed by a doctor
• ​children under 2 years of age: ​ask a doctor

Other information

• ​each softgel contains: ​sodium 7mg
• store between 15° to 30°C (59° to 86°F)
• Protect from moisture

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol.

Questions?

call toll-free ​1-800-935-6737

*This product is not manufactured or distributed by the owner of the registered trademark Colace®. Distributed by: ​Magno-Humphries Labs​Tigard, OR 97223 U.S.A. ​Visit our website: www.magno-humphries.com

*This product is not manufactured or distributed by the owner of the registered trademark Colace®.

Distributed by:
​Magno-Humphries Labs​Tigard, OR 97223 U.S.A.
​Visit our website:
www.magno-humphries.com

PRINCIPAL DISPLAY PANEL

DRUG: Stool Softener Docusate Sodium

GENERIC: DOCUSATE SODIUM

DOSAGE: CAPSULE, GELATIN COATED

ADMINSTRATION: ORAL

NDC: 70518-0585-0

NDC: 70518-0585-1

COLOR: red

SHAPE: OVAL

SCORE: No score

SIZE: 12 mm

IMPRINT: SCU1

PACKAGING: 7 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• DOCUSATE SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

• GELATIN, UNSPECIFIED
• WATER
• POLYETHYLENE GLYCOL 400
• GLYCERIN
• SORBITOL

INGREDIENTS AND APPEARANCE

STOOL SOFTENER DOCUSATE SODIUM 
docusate sodium capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0585(NDC:54257-902)
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
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0585-1	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/29/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/29/2017

Labeler - REMEDYREPACK INC. (829572556)