ONELAX- docusate sodium liquid 
Akron Pharma

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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OneLAX
Docusate Sodium Liquid
50 mg/5 mL

Drug Facts

Active ingredient (in each 5 mL)

Docusate Sodium 50 mg

Purpose

Stool Softner Laxative

Uses

Warnings

Do Not Use for more than one week unless directed by a doctor.

Ask a doctor before use if you

Stop use and ask a doctor if

if pregnant or breast-feeding, 

ask doctor before use.

Keep out of reach of children

In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

Directions

Age Dose
 Adults and children over 12 years of age and over 1 to 6 teaspoons (5 mL - 30 mL)
 Children under 12 years of age Ask a doctor

Other information

Inactive ingredients:

Anhydrous citric acid, D&C red#33, Flavor vanilla, Glycerin, Methyl Paraben, Propylene glycol, Propyl paraben, Poloxamer 407, Purified water, Sodium benzoate, Sodium citrate, Sorbitol solution, Sucralose

Questions or comments?

call toll-free 1-877-225-6999

Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
www.akronpharma.com

label

ONELAX 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0039
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)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-0039-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/04/2023
Labeler - Akron Pharma (067878881)

Revised: 8/2023
Document Id: 63dcff8d-8254-450b-b3d0-e28425784eae
Set id: c692c99c-6fc8-42fb-bd8a-25ed4979d70b
Version: 1
Effective Time: 20230813
 
Akron Pharma