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NDC 69618-0043-10 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: 69618-0043-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	69618-0043
Product ID	69618-043_3b94cfb2-6dd2-4b3c-9047-e2a97e458efb
Associated GPIs	46500010300110
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
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	2024-12-31

Package

Package Images

NDC 69618-0043-10 (69618004310)

Pricing Information	N/A
NDC Package Code	69618-043-10
Billing NDC	69618004310
Package	1000 CAPSULE in 1 BOTTLE, PLASTIC (69618-043-10)
Marketing Start Date	2016-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 383ce892-de63-62e8-e054-00144ff88e88 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

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 directed to do so by a doctor

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

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

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding, ask a health professional before use.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

SPL UNCLASSIFIED SECTION

each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink

Questions or comments ?

Call 516-341-066 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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580 www.reliable1labs.com

PRINCIPLINE DISPLAY PANEL - Bottle Label 100ct

NDC 69618-043-01

Docusate Sodium 100 mg 100 SOFTGELS

STOOL SOFTENER LAXATIVE

PRINCIPLINE DISPLAY PANEL - Bottle Label 1000ct

NDC 69618-043-10

Docusate Sodium 100 mg 1000 SOFTGELS

STOOL SOFTENER LAXATIVE

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69618-043
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PC1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69618-043-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016
2	NDC:69618-043-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	04/01/2016

Labeler - Reliable 1 Laboratories LLC (079718111)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(69618-043) , analysis(69618-043)

Revised: 11/2019

Document Id: 3b94cfb2-6dd2-4b3c-9047-e2a97e458efb

Set id: 383ce892-de63-62e8-e054-00144ff88e88

Version: 3

Effective Time: 20191125

Search by Drug Name or NDC

NDC 69618-0043-10 Docusate Sodium 100 mg/1 Details

Docusate Sodium 100 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 69618-0043-10 (69618004310)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 383ce892-de63-62e8-e054-00144ff88e88 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each softgel)

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

SPL UNCLASSIFIED SECTION

Inactive ingredients

Questions or comments ?

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPLINE DISPLAY PANEL - Bottle Label 100ct

PRINCIPLINE DISPLAY PANEL - Bottle Label 1000ct

INGREDIENTS AND APPEARANCE

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