Docusate Sodium by McKesson Corporation dba SKY Packaging DOCUSATE SODIUM liquid

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by McKesson Corporation dba SKY Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

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	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: 63739-976-10	10 in 1 CASE	05/01/2023	02/28/2026
1		10 in 1 TRAY
1	NDC: 63739-976-01	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	02/28/2026

Labeler - McKesson Corporation dba SKY Packaging (140529962)