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

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Docusate Sodium - Stool Softener Laxative

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

• for relief of occasional constipation (irregularity)
• This generally produces a bowel movement within 12 to 72 hours.

Warnings

Ask a doctor before use if you have
• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if
• you have rectal bleeding or no bowel movement after using this product.
These can be signs of a serious condition
• you need to use a laxative for more than 1 week

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

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

Keep out of reach of children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• take softgel with a full glass (8 oz) of water

adults and children 12 years of age and older

take 1 to 3 softgels daily or as directed
by a doctor. This dose may be taken as a single daily dose or in divided doses.

children 6 to under 12 years of age

take 1 softgel daily or as directed by a doctor

children under 6 years of age

ask a doctor

Other information

each softgel contains: sodium 10 mg (very low sodium)
• store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).

Inactive ingredients

edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments? 

(800)616-2471

Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152

Distributed By:

Cardinal Health

Dublin, OH 43017

L57466800124


Product of UAE
Packaged and Quality Assured in the USA

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

READ FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Principal Display Panel

Docusate Sodium

100 mg

10 Softgels

Bag Label
DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-3369(NDC:0904-7183)
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code 777
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-3369-010 in 1 BAG09/04/2021
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 DrugM00709/04/2021
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 1/2024
Document Id: 736ce3ba-6b8f-412f-8960-465c3b01b559
Set id: b5e4b14d-bf11-4309-bf6d-65ee9d877a24
Version: 4
Effective Time: 20240109
 
Cardinal Health 107, LLC