DOCU LIQUID- docusate sodium liquid 
Akorn Operating Company LLC

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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Drug Facts

Active ingredient

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Keep Out of Reach of Children

Uses

relieves occasional constipation
generally produces bowel movement in 12-72

Warnings

Do Not Use

if you are presently taking mineral oil
when abdominal pain, nausea, or vomiting are present
for longer than one week

Ask a doctor before use if you have

noticed a sudden change in bowel habits that lasts over two weeks.

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use of this product

These may indicate a serious condition.

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

may be taken once daily or in divided doses
give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

adults and children over 12

1 to 7 teaspoons

children 2 to under 12

1 to 3 teaspoons

children under 2

ask a doctor

Other information

each teaspoon contains: sodium 5 mg
shake well before using
store at controlled room temperature 15° - 30°C (59° - 86°F)
dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP
store in an upright position

Inactive Ingredients

D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions or comments?

Call 1-800-932-5676

Mon - Thurs. 9:00 am - 4:30 pm EST, Fri. 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

container label

NDC 50383-771-16

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

STOOL SOFTENER LAXATIVE

TAMPER EVIDENT: FOR YOUR PROTECTION THE CHILD RESISTANT CAP HAS A PRINTED SAFETY SEAL AROUND THE NECK. DO NOT ACCEPT IF BROKEN OR MISSING.

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

NET CONTENTS ONE PINT (473 mL)

Package/Label Principal Display Panel

Unit Dose Lid

Delivers 10 mL

NDC 50383-349-10

DOCU LIQUID

(DOCUSATE SODIUM)

100 mg/ 10 mL

STOOL SOFTENER LAXATIVE

SEE INSERT

Barcode 3 5038334910 5

FOR INSTITUTIONAL USE ONLY

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

Rev. 349:01 04/22

DOCU LIQUID 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-771
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
POLOXAMER 181 (UNII: 09Y8E6164A)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorVANILLA (natural and artificial flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50383-771-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/01/1997
DOCU LIQUID 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-349
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
POLOXAMER 181 (UNII: 09Y8E6164A)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorVANILLA (natural and artificial flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50383-349-1110 in 1 CASE05/28/2021
110 in 1 TRAY
1NDC:50383-349-1010 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 not finalpart33408/01/1997
Labeler - Akorn Operating Company LLC (117696873)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn Operating Company LLC117696873MANUFACTURE(50383-771, 50383-349) , PACK(50383-771, 50383-349)

Revised: 10/2022
Document Id: 5ac421b1-7808-4afb-8e1c-706b77b0e090
Set id: 7fdc4368-4888-4792-86d3-c8a828e4fff2
Version: 9
Effective Time: 20221013
 
Akorn Operating Company LLC