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NDC 69618-0044-10 Docusate Sodium 100 mg/1 Details

Docusate Sodium 100 mg/1

Docusate Sodium is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Reliable-1 Laboratories 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: 69618-0044-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	69618-0044
Product ID	69618-044_e670daa7-a1cb-8ab3-e053-2a95a90aa17d
Associated GPIs	46500010300110
GCN Sequence Number	003009
GCN Sequence Number Description	docusate sodium CAPSULE 100 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09101
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
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Reliable-1 Laboratories 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 69618-0044-10 (69618004410)

Pricing Information	N/A
NDC Package Code	69618-044-10
Billing NDC	69618004410
Package	1000 CAPSULE in 1 BOTTLE, PLASTIC (69618-044-10)
Marketing Start Date	2017-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 597bab7a-3b62-1083-e053-2a91aa0a9d48 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each softgel)

Docusate sodium 100 mg

SPL UNCLASSIFIED SECTION

Purpose

Stool softener laxative

SPL UNCLASSIFIED SECTION

Uses

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

SPL UNCLASSIFIED SECTION

Warnings

Do not use if you are presently taking mineral oil, unless directed 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

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 or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use stool softner 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.

SPL UNCLASSIFIED SECTION

Directions

adults and children 12 years and over	take 1 - 3 softgels once daily or in divded doses
children 2 to under 12 years of age	1 softgel once daily
children under 2 years	ask a doctor

SPL UNCLASSIFIED SECTION

Other information

each softgel contains: s odium 7 mg
store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat

SPL UNCLASSIFIED SECTION

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

SPL UNCLASSIFIED SECTION

Questions or comments? Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Colace®

Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580

www.reliable1labs.com

Made in Romania

PRINCIPAL DISPLAY PANEL

NDC 69618-044-10

*Compare to the active ingredient in Colace®

Reliable-1™ LABORATORIES

Docusate Sodium 100 mg

STOOL SOFTENER LAXATIVE

1000 SOFTGELS

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69618-044
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
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	SCU1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69618-044-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2017
2	NDC:69618-044-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/01/2017

Labeler - Reliable-1 Laboratories LLC (079718111)

Revised: 8/2022

Document Id: e670daa7-a1cb-8ab3-e053-2a95a90aa17d

Set id: 597bab7a-3b62-1083-e053-2a91aa0a9d48

Version: 4

Effective Time: 20220817

Search by Drug Name or NDC

NDC 69618-0044-10 Docusate Sodium 100 mg/1 Details

Docusate Sodium 100 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 69618-0044-10 (69618004410)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 597bab7a-3b62-1083-e053-2a91aa0a9d48 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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