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

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Docusate Sodium, USP

Stool Softener

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

For the relief of occasional constipation.
Helps to prevent dry, hard stools.
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 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 two weeks.

Stop use and ask a doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If you are pregnant or breast-feeding,

ask a healthcare professional before use.

Directions

Adults and Children over 12 years of age

Take orally 1 softgel preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

Each softgel contains 13 mg of Sodium.                    
Store at room temperature between 15°C to 30°C (59°F to 86°F).
For identification purposes, each softgel will have an imprint that reads NV12.
Bend at perforation before tearing

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol

Questions

Call 1-855-361-3993

Generic Section

Manufactured for

AvKARE

Pulaski, TN 38478

AVPAK™

A PRODUCT OF AvKARE

Made in USA

Mfg. Formula 8064

Distributed by:

Cardinal Health

Dublin, OH 43017

L5365630-10721

Principal Display Panel

Docusate Sodium, USP

Stool Softener

250 mg

10 Softgels

bag label
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4341(NDC:50268-268)
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 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize20mm
FlavorImprint Code NV12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-4341-010 in 1 BAG05/17/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00705/17/2017
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 11/2023
Document Id: 52f6e766-b88e-43fc-9c8f-e08b82e4ee8c
Set id: 2e92ab21-6e5f-4c85-85f9-931d2d573e05
Version: 4
Effective Time: 20231103
 
Cardinal Health 107, LLC