Docusate Sodium by Belleview Bio Science DOCUSATE SODIUM liquid

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Belleview Bio Science. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 10 mL)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

• relieves of occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

• for more than 1 week unless directed by a doctor
• if you are currently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that persist over a period of 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or failure to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• a skin rash occurs
• you experience throat irritation

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

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

Directions

• shake well before using
• must be given in a 6 oz to 8 oz glass of milk, fruit juice or infant formula to mask the bitter taste and prevent throat irritation
• take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
• do not exceed recommended dose
• follow dosing directions below or use as directed by a doctor

• Age: Dose
• adults and children 12 years and older: 1 to 7 teaspoonfuls
• children 2 to under 12 years of age: 1 to 3 teaspoonfuls
• children under 2 years of age: ask a doctor

Other Information

• store at controlled room temperature 20ºC to 25ºC (68ºF to 77ºF)
• protect from light
• protect from excessive heat
• protect from freezing
• clear, grape-flavored liquid, supplied in the following:

NDC: 81033-022-10: 10 mL unit dose cup

NDC: 81033-022-50: Case containing 100 unit dose cups of 10 mL each

Inactive ingredients

citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Questions or comments?

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

Packaged by:

Kesin Pharma

Oldsmar, FL 34677

Rev. 04/2025

PRINCIPAL DISPLAY PANEL

BULK SHIPMENT: For institutional or repackaging use only.

Docusate Sodium Liquid

50 mg per 5 mL

200,00 mL

NDC: 8447-011-01

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84447-011
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  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GRAPE (UNII: 6X543N684K)
SORBITOL (UNII: 506T60A25R)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84447-011-01	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	03/01/2025

Labeler - Belleview Bio Science (131968803)

Establishment
Name	Address	ID/FEI	Business Operations
Belleview Bio Science		131968803	manufacture(84447-011) , analysis(84447-011) , label(84447-011)