STOOL SOFTENER LIQUID- docusate sodium liquid 
ATLANTIC BIOLOGICALS CORP.

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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GNP DOCUSATE LIQUID

Active ingredient (in each 5 mL teaspoonful)

Docusate Sodium 50 mg

Purpose

Stool Softener 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 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

Adults and children 12 years and over
1 to 4 teaspoonfuls (5 to 20 mL)
Children under 12 years of age
ask a doctor

Other information

Inactive ingredients

citric acid, D&C Red #33, flavor, parabens, poloxamer, polyethylene glycol, sodium citrate, sorbitol, sucrose, and water.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE 

MIAMI, FL 33179

package label

NDC 17856-0398-1

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
250mg/25 mL 

50 cups per case

image 1

NDC 17856-0398-2

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
100mg/10 mL

72 cups per case

image 2

STOOL SOFTENER LIQUID 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0398(NDC:46122-399)
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)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SUCROSE (UNII: C151H8M554)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0398-150 in 1 BOX, UNIT-DOSE01/18/2021
125 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-0398-272 in 1 BOX, UNIT-DOSE01/18/2021
210 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 finalpart33409/01/2017
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0398) , repack(17856-0398)

Revised: 1/2021
Document Id: 42953e6a-873c-4c32-afa7-94196611cc1c
Set id: 3bcab14d-a4b2-433a-9d1f-5dec61c7ae24
Version: 2
Effective Time: 20210118
 
ATLANTIC BIOLOGICALS CORP.