Docusate Sodium by Cardinal Health DOCUSATE SODIUM liquid

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Distributed By:

Cardinal Health

Dublin, OH 43017

L32992030218

T0544100419

R04/19

Principal Display Panel

Docusate Sodium Liquid

100 mg/ 10mL

Stool Softener Laxative

5 Cups

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Cardinal Health (603638201)