DOCUSATE SODIUM- docusate sodium liquid
McKesson Corporation dba SKY Packaging

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 10 mL)

Docusate sodium 100 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 63739-976-01: 10 mL Unit Dose Cup

NDC 637369-976-10: 1 case of 100 x 10 mL Unit Dose 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

DISTRIBUTIONED BY

SKY/McKesson Corporation

dba SKY Packaging

Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

Delivers 10 mL

NDC 63739-976-01

Docusate Sodium Liquid

100 mg/ 10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

FOR INSTITUTIONAL USE ONLY

Dist. by: SKY Packaging

Memphis, TN 38141

SEE DRUG FACTS

F0935C101022

PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label

DOCUSATE SODIUM
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63739-976(NDC:0121-0935)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63739-976-10	10 in 1 CASE	05/01/2023
1		10 in 1 TRAY
1	NDC:63739-976-01	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	08/16/2021

Labeler - McKesson Corporation dba SKY Packaging (140529962)

Revised: 8/2023

Document Id: e1e541e5-2ddf-4a76-bd6a-d329bd291a2c

Set id: 557d0f60-9e4b-418e-8a8b-dd93bdf994e2

Version: 5

Effective Time: 20230803

McKesson Corporation dba SKY Packaging