STOOL SOFTENER- docusate sodium 100 mg capsule, liquid filled 
We Care Distributor 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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STOOL SOFTENER - Docusate Sodium Softgels, 100 mg

Drug Facts

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

Principal Display Panel - 50 Pouch Box

STOOL SOFTENER 
docusate sodium 100 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeOVALSize10mm
FlavorImprint Code 125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-015-2525 in 1 BOX
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:70005-015-5050 in 1 BOX
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:70005-015-022 in 1 POUCH
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/07/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PVT LTD677385498manufacture(70005-015)

Revised: 3/2016
Document Id: 5d23093e-30d7-488d-8df2-0ec78055321b
Set id: 299ac7ea-3335-4d9d-893d-1ace0984b03e
Version: 7
Effective Time: 20160309
 
We Care Distributor Inc.