DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Asclemed USA, Inc.

----------

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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

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

Directions

• do not exceed recommended dose
• adults and children 12 years and older: take 1-3
softgels daily until first bowel movement; 1 softgel
daily thereafter, or as directed by a doctor
• children under 12: consult a doctor

Other information

each softgel contains: sodium 7 mg. Very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
Tamper Evident: Do not use if imprinted seal
under cap is missing or broken.

Inactive ingredients

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

Repackaged/Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501

Package Label

1

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-225(NDC:57896-401)
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)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
Colorred (reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76420-225-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/07/2022
2NDC:76420-225-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/07/2022
3NDC:76420-225-9090 in 1 BOTTLE; Type 0: Not a Combination Product07/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/01/2000
Labeler - Asclemed USA, Inc. (059888437)
Establishment
NameAddressID/FEIBusiness Operations
ASCLEMED USA INC. DBA ENOVACHEM059888437repack(76420-225) , relabel(76420-225)

Revised: 10/2023
Document Id: 07cec8ef-ecca-ac49-e063-6294a90a6083
Set id: 30fc8c07-c26b-4bcc-a727-6e193f5727fd
Version: 2
Effective Time: 20231016
 
Asclemed USA, Inc.