DOCUSATE SODIUM- docusate sodium capsule 
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 250 mg

Active ingredient

In each softgel: Docusate Sodium 250 mg

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 right away. This unit dose package is not child resistant.

Uses

For the prevention of dry, hard stools and for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Warnings

This package is intended for institutional use only. If pregnant or breast-feeding, ask a health professional before use.

Do not use if you are currently taking mineral oil, unless directed by a doctor, when abdominal pain, nausea, or vomiting are present or for more than one week unless directed by a doctor.

Ask a doctor before use if you notice 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 or if you fail to have a bowel movement after use.

Directions

Adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
Children under 12 years of age: take as directed by a doctor

Inactive ingredients

Edible white printing ink, FD&C red #40, FD&C Yellow #6, gelatin, glycerin USP, polyethylene glycol USP, propylene glycol USP, purified water USP, Sorbitol SpecialTM (Sorbitol, sorbitol anhydrides, purified water, and mannitol).

Storage

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

Each softgel contains: sodium 13.802 mg very low sodium

Do not use if blister units are torn, broken or show any signs of tampering.

Manufactured by:

Banner Pharmacaps Inc.

High Point, NC 27265

Distributed by:

UDL LABORATORIES, INC.

ROCKFORD, IL 61103

Questions? 1-800-848-0462

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Docusate Sodium Softgel

250 mg

Stool Softener

10 Softgels

bag label
DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5474(NDC:51079-048)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorORANGE (clear bright orange) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code P20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-5474-010 in 1 BAG06/26/200209/30/2010
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 other06/26/200209/30/2010
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-5474)

Revised: 6/2018
 
Cardinal Health