DOCUSATE SODIUM- docusate sodium liquid 
Cardinal Health 107, LLC

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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° 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:

Overbagged with 5 x 10 mL unit dose cups in each bag, NDC 55154-2346-5

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

R06/22

Distributed by:

MAJOR® PHARMACEUTICALS 

Indianapolis, IN 46268

Distributed By:

Cardinal Health

Dublin, OH 43017

L58458961223

Principal Display Panel

DOCUSATE SODIUM LIQUID

100 MG / 10 mL

5 CUPS

Bag Label
DOCUSATE SODIUM 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-2346(NDC:0904-7279)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
Colorpink (Clear pink to purple-pink) Score    
ShapeSize
FlavorCHERRY (Cherry-Vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-2346-55 in 1 BAG12/26/2023
110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00712/26/2023
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 7/2024
Document Id: ee14dfe2-405f-493a-a774-ce1b01d05dd4
Set id: ee14dfe2-405f-493a-a774-ce1b01d05dd4
Version: 1
Effective Time: 20240702
 
Cardinal Health 107, LLC