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Docusate Sodium

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 250mg
Labeler: Cardinal Health
NDC Code: 55154-5474

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.

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

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5474(NDC:51079-048)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
MANNITOL 
Product Characteristics
ColorORANGE (clear bright orange) Scoreno score
ShapeOVALSize13mm
FlavorImprint CodeP20
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-5474-010 BLISTER PACK (BLISTER PACK) in 1 BAG
11 CAPSULE (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/02/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 06/2011
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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