DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Cardinal Health 107, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100mg

Purpose

Stool Softener

Uses

for the 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 currently 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 persists 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 you are pregnant or breast-feeding, ask a health professional before use. 

This unit dose package is not child resistant and is Intended for Institutional Use Only.

Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

This package is intended for institutional use only.

Consult a physician before the use of this product.

Directions

Adults and children over 12 years of age and over: take 1-3 softgels daily. This dose may be taken as a 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 capsule contains: sodium 5 mg
store at controlled room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

FD&C Red No. 40, FD&C Yellow No.6, Gelatin, Bovine Bone, Glycerol Palm Free, Polyethylene Glycol 400 NF, Purified Water, Sorbitol Special 76%.

SKY

Mfg. By:

Aenova Holding GmbH

14193 SW 119th Ave.,

Miami, FL 33186-6013

Distributed by

McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Road

Concord, NC 28027

Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids

www.PROmanager-Rx.com

Distributed by

Cardinal Health

Dublin, OH 43017

L44377781018

Principal Display Panel - Bag

Docusate Sodium 100 MG Softgels

10 Softgels

bag label
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1485(NDC:63739-478)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorRED (Reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1485-010 in 1 BAG11/08/201004/30/2021
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/08/201004/30/2021
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 11/2022
 
Cardinal Health 107, LLC