Docusate Sodium by PAI Holdings, LLC dba PAI Pharma / PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma DOCUSATE SODIUM liquid

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by PAI Holdings, LLC dba PAI Pharma, PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma. 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° to 25°C (68° to 77°F)
Protect from freezing
Protect from light
Clear pink to purple-pink colored, cherry flavored liquid supplied in the following:

NDC: 0121-0935-16: 16 fl oz (473 mL) bottle
NDC: 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups.
NDC: 0121-1870-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.

Questions or comments?

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

R12/20

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 ML)

NDC: 0121-0935-16

Docusate Sodium Liquid

50 mg/5 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

16 fl oz (473 mL)

Pharmaceutical Associates, Inc.

Greenville, SC 29605

X0935160721 R07/21

PRINCIPAL DISPLAY PANEL - 5 mL Cup LIdding

NDC: 0121-0935-05

Docusate Sodium Liquid

50 mg/5 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding

NDC: 0121-1870-10

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0935
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	pink (Clear pink to purple-pink)	Score
Shape		Size
Flavor	CHERRY (Cherry-Vanilla)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-0935-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2021	10/31/2025
2	NDC: 0121-0935-40	4 in 1 CASE	08/16/2021
2		10 in 1 TRAY
2	NDC: 0121-0935-05	5 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 Drug	M007	08/16/2021

DOCUSATE SODIUM 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-1870
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	purple (Clear pink to purple-pink)	Score
Shape		Size
Flavor	CHERRY (Cherry-Vanilla)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-1870-00	10 in 1 CASE	08/16/2021
1		10 in 1 TRAY
1	NDC: 0121-1870-10	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 Drug	M007	08/16/2021

Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma		097630693	analysis(0121-0935, 0121-1870) , label(0121-0935, 0121-1870) , manufacture(0121-0935, 0121-1870)