DailyMed - DOCUSATE SODIUM liquid

NDC Code(s): 84447-011-01
Packager: Belleview Bio Science

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated April 22, 2025

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

Active Ingredient (in each 10 mL)
Docusate Sodium 100 mg

Docusate Sodium 100 mg
Close
Purpose
Stool Softener Laxative

Stool Softener Laxative
Close
Uses
relieves of occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
- relieves of occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Close
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 ...
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.

Close
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 ...
- 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
1 teaspoonful = 5 mL

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

Close
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 ...
- 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
Close
Inactive ingredients
citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose
Close
Questions or comments?
Call 1-833-537-4679

Call 1-833-537-4679
Close
SPL UNCLASSIFIED SECTION
Packaged by: Kesin Pharma - Oldsmar, FL 34677 - Rev. 04/2025

Packaged by:

Kesin Pharma

Oldsmar, FL 34677

Rev. 04/2025

Close
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

BULK SHIPMENT: For institutional or repackaging use only.

Docusate Sodium Liquid

50 mg per 5 mL

200,00 mL

NDC: 8447-011-01

Close

1 teaspoonful = 5 mL
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

INGREDIENTS AND APPEARANCE

Product Information

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

View All Sections

	RxCUI	RxNorm NAME	RxTTY
1	1248119	docusate sodium 50 MG in 5 mL Oral Suspension	PSN
2	1248119	docusate sodium 10 MG/ML Oral Suspension	SCD
3	1248119	docusate sodium 100 MG per 10 ML Oral Suspension	SY
4	1248119	docusate sodium 150 MG per 15 ML Oral Suspension	SY
5	1248119	docusate sodium 50 MG per 5 ML Oral Suspension	SY
6	1248119	DOSS Sodium 10 MG/ML Oral Suspension	SY

Label: DOCUSATE SODIUM liquid

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: DOCUSATE SODIUM liquid

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

DOCUSATE SODIUM liquid

Number of versions: 1

DOCUSATE SODIUM liquid

DOCUSATE SODIUM liquid

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

DOCUSATE SODIUM liquid

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.