DOCUSATE SODIUM- docusate sodium liquid
Cardinal Health 107, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Docusate Sodium

Drug Facts

Active ingredient (in each 5 mL)

Docusate sodium 50 mg

Purpose

Stool softener

Uses

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

Warnings

Do not use

•: if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

•: stomach pain
•: nausea
•: vomiting
•: noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

•: you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
•: you need to use a stool softener laxative for more than 1 week
•: rash occurs

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

•: Dose once daily
•: take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.

adults and children 12 years and older	5 to 20 mL (1 to 4 teaspoonfuls)
children 6 to under 12 years of age	5 to 10 mL (1 to 2 teaspoonfuls)
children 3 to under 6 years of age	2.5 to 5 mL (1/2 to 1 teaspoonful)
children under 3 years	ask a doctor

Other information

•: Sodium content: 14 mg/ 5 mL
•: Store at controlled room temperature, 20° - 25°C (68° - 77°F)
•: Protect from freezing
•: Protect from light
•: Purple colored, cherry flavored liquid supplied in the following:
Overbagged with 5 x 10 mL cups per bag, NDC 55154-9401-5

Inactive ingredients

Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

Questions or comments?

Call 1-800-845-8210

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Distributed By:

Cardinal Health

Dublin, OH 43017

L32992030421

R11/20

PRINCIPAL DISPLAY PANEL

Docusate Sodium Liquid

100 mg/ 10mL

Stool Softener Laxative

5 Cups

DOCUSATE SODIUM
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-9401(NDC:0121-0544)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-9401-5	5 in 1 BAG	02/16/1983	02/28/2014
1		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/16/1983	02/28/2014

Labeler - Cardinal Health 107, LLC (118546603)

Revised: 1/2023

Document Id: 9598f132-b04e-443c-87b6-2f3d54a1c00a

Set id: 0f385e4b-00f5-403a-9952-3c847dba742f

Version: 10

Effective Time: 20230118

Cardinal Health 107, LLC