DOCUSATE SODIUM 100MG- docusate sodium 100mg- docusate sodium capsule, liquid filled capsule, liquid filled

DOCUSATE SODIUM 100MG by

Drug Labeling and Warnings

DOCUSATE SODIUM 100MG by is a Otc medication manufactured, distributed, or labeled by SHANDONG ROSEMED BIOOHARM LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each s oftgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have

• stomach pain, nausea or vomitting
• a sudden change in bowel habits that lasts more than 2 weeks

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 could 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 professional before use.

Directions

take with a glass of water

adults and children 12 years and over	1 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 age	1 softgel daily
children under 2 years of age	ask a doctor

Other information

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

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 over: 1 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 age: 1 softgel daily
• children under 2 years of age: ask 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

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 100MG 
docusate sodium 100mg- docusate sodium capsule, liquid filled capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84328-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	score with uneven pieces
Shape	CAPSULE (OVAL)	Size	13mm
Flavor		Imprint Code	655
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84328-001-01	1 in 1 BOX	05/16/2024
1		20000 in 1 BAG; Type 0: Not a Combination Product
2	NDC: 84328-001-02	1 in 1 BOX	05/17/2024
2		15000 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	05/16/2024

Labeler - SHANDONG ROSEMED BIOOHARM LLC (416829348)

Registrant - SHANDONG ROSEMED BIOOHARM LLC (416829348)

Establishment
Name	Address	ID/FEI	Business Operations
SHANDONG ROSEMED BIOOHARM LLC		416829348	manufacture(84328-001)