Docusate Sodium by Pharmaceutical Associates, Inc. DOCUSATE SODIUM liquid

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. 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:

• NDC: 0121-0544-16: 16 fl oz (473 mL) bottle
• NDC: 0121-0544-10: 10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.
• NDC: 0121-0544-25: 25 mL unit dose cup. Case contains 100 unit dose cups of 25 mL packaged in 10 trays of 10 unit dose cups each.

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

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

NDC: 0121-0544-10

Docusate Sodium Liquid
(SUGAR FREE)

100 mg/10 mL

STOOL SOFTENER LAXATIVE

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

Store at 20° - 25°C (68° - 77°F)
[See USP Controlled Room Temperature].

10 x 10 mL Unit-Dose Cups

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

T0544100419
R04/19

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 0121-0544-16	12 in 1 CASE	02/16/1983
1		473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0121-0544-10	10 in 1 CASE	02/16/1983
2		10 in 1 TRAY
2		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC: 0121-0544-25	10 in 1 CASE	02/16/1983
3		10 in 1 TRAY
3		25 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 - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0544)