DOCUSATE SODIUM- docusate sodium liquid
Pharmaceutical Associates, Inc.

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.

----------

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:

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

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

R11/20

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

T0544101120 R11/20

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

DOCUSATE SODIUM
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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:0121-0544-16	12 in 1 CASE	02/16/1983	02/28/2014
1		473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0121-0544-10	10 in 1 CASE	02/16/1983	02/28/2014
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	02/28/2014
3		10 in 1 TRAY
3		25 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 - Pharmaceutical Associates, Inc. (044940096)

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

Revised: 12/2022

Document Id: eede7f2b-c0af-2e49-e053-2995a90a2731

Set id: 1fcb6361-7598-4ac9-b04d-faf4397197eb

Version: 7

Effective Time: 20221202

Pharmaceutical Associates, Inc.