DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Cardinal Health

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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Docusate Sodium 100 mg

Active ingredient

Each softgel contains: Docusate Sodium, 50% w/w in polyethylene glycol 400 (provides 100 mg Docusate Sodium)

Purpose

Stool Softener

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center Immediately

Uses

Use as a stool softener for the temporary relief of occasional constipation. This product generally produces a bowel movement in 12 to 72 hours.

Warnings

This package is intended for institutional use only. Do not use the product if abdominal pain, nausea or vomiting are present.

Consult a physician before the use of this product.

Ask a doctor before use if: You have noticed a sudden change in bowel habits that persist over a period of 2 weeks. You are presently taking mineral oil.

Stop use and ask a doctor if: Rectal bleeding or failure to have a bowel movement occur after use, which may indicate a serious condition.

You need to use a laxative for more than 1 week.

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

Directions

Adults and children 12 years of age and over. Take 1 to 3 softgels daily. Children 6 to under 12 years. Take 1 softgel daily. Children under 6 years consult a doctor.

Inactive ingredients

Gelatin, Polyethylene Glycol 400, Sorbitol SpecialTM(Sorbitol, sorbitol anhydrides, purified water and mannitol), Glycerin, Purified Water, Propylene Glycol, FD&C Red #40, FD&C Yellow #6, Edible white printing ink.

Sodium Content: 5 mg per softgel.

Storage

Store at 15-30 C (59-86 F)

Protect from excessive moisture.

SKY

Mfg. By: Banner Pharmacaps® High Point, NC USA 27265

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

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Docusate Sodium 100 MG SOFGELSTM

STOOL SOFTENER

10 Softgels

bag label
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1477(NDC:63739-089)
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
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
MANNITOL (UNII: 3OWL53L36A)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGE (clear bright orange) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1477-010 in 1 BAG06/02/201106/16/2011
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 other06/02/201106/16/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-1477)

Revised: 8/2017
 
Cardinal Health