STOOL SOFTENER- docusate sodium 100 mg capsule, liquid filled

STOOL SOFTENER by

Drug Labeling and Warnings

STOOL SOFTENER by is a Otc medication manufactured, distributed, or labeled by We Care Distributor Inc., MEDGEL PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)                 Purpose

Docusate sodium 100 mg..............................Stool softener

Uses

■ for prevention of dry, hard stools

■ for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

■ if you are presently taking mineral oil, unless directed by a doctor

■ when abdominal pain, nausea, or vomiting are present

■ for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have

noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

■ you have rectal bleeding

■ you fail to have a bowel movement after use

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 with a glass of water

■ adults and children 12 years of age and over: take 1 to 3 softgels daily. This dose may be taken as single daily dose or in divided doses.

■ children 2 to under 12 years of age: take 1 softgels daily

■ children under 2 years of age: consult a physician.

Other information

■ each softgel contains sodium 6 mg

■ store at controlled room temperature 15°-30°C (59°-86°F)

■ read all product information before using

Inactive ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Dulcolax® Stool Softener

STOOL SOFTENER

Docusate Sodium Softgels, 100 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Softgels Each

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium 100 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-015
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-015-25	25 in 1 BOX
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 70005-015-50	50 in 1 BOX
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 70005-015-02	2 in 1 POUCH
3		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/07/2016

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PVT LTD		677385498	manufacture(70005-015)