DOCUSATE SODIUM 100MG- docusate sodium 100mg- docusate sodium capsule, liquid filled capsule, liquid filled 
SHANDONG ROSEMED BIOOHARM LLC

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Drug Facts

Active ingredient (in each s oftgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

Warnings

Ask a doctor before use if you have

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

Stop use and ask a doctor if

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

Directions

take with a glass of water

adults and children 12 years and over1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 and under 12 years of age1 softgel daily
children under 2 years of ageask a doctor

Other information

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

Dosage & administraton

each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity

Indications & usage section

adults and children 12 years and over1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 and under 12 years of age1 softgel daily
children under 2 years of ageask a doctor

keep out of reach of children

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

Drug Label Information

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 20000 Capsules
NDC. No : 84328-001

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

1

DOCUSATE SODIUM 100MG 
docusate sodium 100mg- docusate sodium capsule, liquid filled capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84328-001
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorredScorescore with uneven pieces
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint Code 655
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84328-001-011 in 1 BOX05/16/2024
120000 in 1 BAG; Type 0: Not a Combination Product
2NDC:84328-001-021 in 1 BOX05/17/2024
215000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00805/16/2024
Labeler - SHANDONG ROSEMED BIOOHARM LLC (416829348)
Registrant - SHANDONG ROSEMED BIOOHARM LLC (416829348)
Establishment
NameAddressID/FEIBusiness Operations
SHANDONG ROSEMED BIOOHARM LLC416829348manufacture(84328-001)

Revised: 8/2024
Document Id: 2091a352-e44b-2bba-e063-6294a90a00f8
Set id: 188d20f5-43de-d52a-e063-6394a90a451a
Version: 2
Effective Time: 20240826
 
SHANDONG ROSEMED BIOOHARM LLC