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NDC 68094-0052-61 Docusate Sodium 250 mg/1 Details

Docusate Sodium 250 mg/1

Docusate Sodium is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Precision Dose, 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: 68094-0052-61
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	68094-0052
Product ID	68094-052_5fb1f9b8-3b86-4009-ad70-e115b351cf4e
Associated GPIs
GCN Sequence Number	003011
GCN Sequence Number Description	docusate sodium CAPSULE 250 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09102
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, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	250
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Precision Dose, 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 68094-0052-61 (68094005261)

Pricing Information
NDC Package Code	68094-052-61
Billing NDC	68094005261
Package	10 BLISTER PACK in 1 CARTON (68094-052-61) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68094-052-59)
Marketing Start Date	2022-09-30
NDC Exclude Flag	N
Price Per Unit	0.05018
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	DOCUSATE SODIUM 250 MG SOFTGEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL f8da3187-55d4-4e6f-a8ed-a0f76744e7ee Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Uses

For the relief of occasional constipation.
Helps to prevent dry, hard stools.
This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS

Do not use

If you are currently taking mineral oil, unless directed by a doctor.
When abdominal pain, nausea or vomiting are present.
For longer than one week unless directed by a doctor.

Ask a doctor before use if you noticed a sudden change in bowel habits that persists over a period of two weeks.

Stop use and ask a doctor if

You have rectal bleeding.
You fail to have a bowel movement after use.

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

Adult and Children over 12 years of age	Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under 12 years of age	Do not use this product for children under 12 years of age, unless directed by a doctor.

Other information

Each softgel contains 13 mg of Sodium.
Store at room temperature between 15°C to 25°C (59°F to 77°F).

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

How Supplied

NDC 68094-052-61

Unit Dose Packages of 100 Softgels (10×10) per Carton

SPL UNCLASSIFIED SECTION

Distributed by:

National Vitamin Company

Casa Grande, AZ 85122

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080

SPL UNCLASSIFIED SECTION

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

SPL UNCLASSIFIED SECTION

LI1459 Rev. 06/21

PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton

Precision Dose™

NDC 68094-052-61

Unit Dose

Docusate Sodium, USP

250 mg Softgels

100 Softgels

(10 x 10)

(in each softgel)

Docusate Sodium 250 mg Stool Softener

Each softgel contains 13 mg of Sodium.

USUAL DOSE: SEE ENCLOSED INSERT.

Store at room temperature between

15°C to 25°C (59°F to 77°F).

Keep out of reach of children.

Hospital Use Only.

LC1458

R0

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68094-052(NDC:54629-601)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	NV12
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68094-052-61	10 in 1 CARTON	09/30/2022
1	NDC:68094-052-59	10 in 1 BLISTER PACK; 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	09/30/2022

Labeler - Precision Dose, Inc. (035886746)

Name	Address	ID/FEI	Business Operations
Establishment
Precision Dose, Inc.		035886746	REPACK(68094-052)

Revised: 9/2022

Document Id: 5fb1f9b8-3b86-4009-ad70-e115b351cf4e

Set id: f8da3187-55d4-4e6f-a8ed-a0f76744e7ee

Version: 1

Effective Time: 20220916

Search by Drug Name or NDC

NDC 68094-0052-61 Docusate Sodium 250 mg/1 Details

Docusate Sodium 250 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68094-0052-61 (68094005261)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f8da3187-55d4-4e6f-a8ed-a0f76744e7ee Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each softgel)

Purpose

Uses

WARNINGS

Do not use

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

How Supplied

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton

INGREDIENTS AND APPEARANCE

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