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NDC 55154-9629-05 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 Cardinal Health 107, 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: 55154-9629-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	55154-9629
Product ID	55154-9629_297b42cd-688c-41ac-a795-eccefdce4f15
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Cardinal Health 107, 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 55154-9629-05 (55154962905)

Pricing Information	N/A
NDC Package Code	55154-9629-5
Billing NDC	55154962905
Package	5 CUP, UNIT-DOSE in 1 BAG (55154-9629-5) / 10 mL in 1 CUP, UNIT-DOSE
Marketing Start Date	1997-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 38f52588-8972-4b5c-805f-19a592f36613 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 1-800-262-9010

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.

Distributed by:

Cardinal Health

Dublin, OH 43017

L55233450619

Principal Display Panel

Docu Liquid 100 mg/10 mL

(Docusate Liquid)

Stool Softener Laxative

5 cups

INGREDIENTS AND APPEARANCE

DOCU LIQUID

docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-9629(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
Packaging
1	NDC:55154-9629-5	5 in 1 BAG	08/01/1997
1		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 - Cardinal Health 107, LLC (118546603)

Revised: 11/2022

Document Id: 297b42cd-688c-41ac-a795-eccefdce4f15

Set id: 38f52588-8972-4b5c-805f-19a592f36613

Version: 4

Effective Time: 20221122

Search by Drug Name or NDC

NDC 55154-9629-05 Docu Liquid 50 mg/5mL Details

Docu Liquid 50 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 55154-9629-05 (55154962905)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 38f52588-8972-4b5c-805f-19a592f36613 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?

Principal Display Panel

INGREDIENTS AND APPEARANCE

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