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NDC 63187-0476-90 Docusate Sodium 100 mg/1 Details

Docusate Sodium 100 mg/1

Docusate Sodium is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0476-90
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	63187-0476
Product ID	63187-476_5346c4b6-824a-4b08-84de-b4f29101f3e9
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	Docusate Sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Proficient Rx LP
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 63187-0476-90 (63187047690)

Pricing Information	N/A
NDC Package Code	63187-476-90
Billing NDC	63187047690
Package	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-476-90)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f9ac0344-5864-4ac1-81bc-16878a5946c5 Details

Active ingredient (in each softgel)

Docusate sodium 100 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 currently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

•: stomach pain, nausea or vomiting
•: have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

•: you have rectal bleeding
•: you fail to have a bowel movement after use
•: you need to use a stool softener laxative for more than 1 week

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

•: doses may be taken as a single daily dose or in divided doses

adults and children 12 years and over	take 1 to 3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

•: each capsule contains sodium 6 mg
•: store at room temperature 15o-30oC (59o-86oF)
•: Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special

Questions?

Adverse drug event call (800) 687-0176

Principal Display Panel

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-476(NDC:66424-030)
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

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (Two toned- white and clear red)	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	51A
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-476-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
2	NDC:63187-476-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
3	NDC:63187-476-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
4	NDC:63187-476-00	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/15/2010

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-476) , RELABEL(63187-476)

Revised: 1/2021

Document Id: 5346c4b6-824a-4b08-84de-b4f29101f3e9

Set id: f9ac0344-5864-4ac1-81bc-16878a5946c5

Version: 3

Effective Time: 20210101