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NDC 00121-0935-40 Docusate Sodium 50 mg/5mL Details

Docusate Sodium 50 mg/5mL

Docusate Sodium is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaceutical Associates, Inc.. 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: 00121-0935-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	00121-0935
Product ID	0121-0935_c9acc4ea-adee-3c73-e053-2a95a90a9702
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	Docusate Sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate Sodium Liquid
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	Pharmaceutical Associates, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00121-0935-40 (00121093540)

Pricing Information	N/A
NDC Package Code	0121-0935-40
Billing NDC	00121093540
Package	4 TRAY in 1 CASE (0121-0935-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0935-05)
Marketing Start Date	2021-08-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Docusate sodium 50 mg

Purpose

Stool softener

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a stool softener laxative for more than 1 week
rash occurs

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

Dose once daily
take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.

adults and children 12 years and older	5 to 20 mL (1 to 4 teaspoonfuls)
children 6 to under 12 years of age	5 to 10 mL (1 to 2 teaspoonfuls)
children 3 to under 6 years of age	2.5 to 5 mL (1/2 to 1 teaspoonful)
children under 3 years	ask a doctor

Other information

• Sodium content: 14 mg/ 5 mL

• Store at controlled room temperature, 20° to 25°C (68° to 77°F)

• Protect from freezing

• Protect from light

• Clear pink to purple-pink colored, cherry flavored liquid supplied in the following:

NDC 0121-0935-16: 16 fl oz (473 mL) bottle

NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups.

NDC 0121-1870-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.

Questions or comments?

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

R12/20

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)

NDC 0121-0935-16

Docusate Sodium Liquid

50 mg/5 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

16 fl oz (473 mL)

Pharmaceutical Associates, Inc.

Greenville, SC 29605

X0935160721 R07/21

PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label

NDC 0121-0935-05

Docusate Sodium Liquid

50 mg/5 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Package Not Child-Reistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

NDC 0121-1870-10

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Package Not Child-Reistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-0935
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
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)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	pink (Clear pink to purple-pink)	Score
Shape		Size
Flavor	CHERRY (Cherry-Vanilla)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-0935-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2021
2	NDC:0121-0935-40	4 in 1 CASE	08/16/2021
2		10 in 1 TRAY
2	NDC:0121-0935-05	5 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	08/16/2021

DOCUSATE SODIUM

docusate sodium liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-1870
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
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)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	purple (Clear pink to purple-pink)	Score
Shape		Size
Flavor	CHERRY (Cherry-Vanilla)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-1870-00	10 in 1 CASE	08/16/2021
1		10 in 1 TRAY
1	NDC:0121-1870-10	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	08/16/2021

Labeler - Pharmaceutical Associates, Inc. (044940096)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0935, 0121-1870)

Revised: 9/2021

Document Id: c9acc4ea-adee-3c73-e053-2a95a90a9702

Set id: e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5

Version: 1

Effective Time: 20210915

Search by Drug Name or NDC

NDC 00121-0935-40 Docusate Sodium 50 mg/5mL Details

Docusate Sodium 50 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00121-0935-40 (00121093540)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

INGREDIENTS AND APPEARANCE

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