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NDC 50383-0349-11 Docu Liquid 50 mg/5mL Details

Docu Liquid 50 mg/5mL

Docu Liquid is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn Operating Company LLC. The primary component is DOCUSATE SODIUM.

MedlinePlus Drug Summary

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 50383-0349-11
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	50383-0349
Product ID	50383-349_5ac421b1-7808-4afb-8e1c-706b77b0e090
Associated GPIs	46500010300910
GCN Sequence Number	003017
GCN Sequence Number Description	docusate sodium LIQUID 50 MG/5 ML ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09131
HICL Sequence Number	001326
HICL Sequence Number Description	DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	Docu Liquid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/5mL
Substance Name	DOCUSATE SODIUM
Labeler Name	Akorn Operating Company LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50383-0349-11 (50383034911)

Pricing Information	N/A
NDC Package Code	50383-349-11
Billing NDC	50383034911
Package	10 TRAY in 1 CASE (50383-349-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (50383-349-10)
Marketing Start Date	2021-05-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7fdc4368-4888-4792-86d3-c8a828e4fff2 Details

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

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

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

INGREDIENTS AND APPEARANCE

DOCU LIQUID

docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50383-771
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	PINK	Score
Shape		Size
Flavor	VANILLA (natural and artificial flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50383-771-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/1997

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	08/01/1997

DOCU LIQUID

docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50383-349
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	PINK	Score
Shape		Size
Flavor	VANILLA (natural and artificial flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50383-349-11	10 in 1 CASE	05/28/2021
1		10 in 1 TRAY
1	NDC:50383-349-10	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	08/01/1997

Labeler - Akorn Operating Company LLC (117696873)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn Operating Company LLC		117696873	MANUFACTURE(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

Search by Drug Name or NDC

NDC 50383-0349-11 Docu Liquid 50 mg/5mL Details

Docu Liquid 50 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 50383-0349-11 (50383034911)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7fdc4368-4888-4792-86d3-c8a828e4fff2 Details

Active ingredient

Purpose

Keep Out of Reach of Children

Uses

Warnings

Do Not Use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep Out of Reach of Children

Directions

Other information

Inactive Ingredients

Questions or comments?

Package/Label Principal Display Panel

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

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