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NDC 54629-0640-01 Docusate Calcium 240 mg sodium free 240 mg/1 Details

Docusate Calcium 240 mg sodium free 240 mg/1

Docusate Calcium 240 mg sodium free is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by National Vitamin Company. The primary component is DOCUSATE CALCIUM.

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: 54629-0640-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	54629-0640
Product ID	54629-640_f06f12d6-1c98-4027-87c7-1140a7740490
Associated GPIs	46500010100105
GCN Sequence Number	003005
GCN Sequence Number Description	docusate calcium CAPSULE 240 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09061
HICL Sequence Number	001324
HICL Sequence Number Description	DOCUSATE CALCIUM
Brand/Generic	Generic
Proprietary Name	Docusate Calcium 240 mg sodium free
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate Calcium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	240
Active Ingredient Units	mg/1
Substance Name	DOCUSATE CALCIUM
Labeler Name	National Vitamin Company
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 54629-0640-01 (54629064001)

Pricing Information	N/A
NDC Package Code	54629-640-01
Billing NDC	54629064001
Package	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-640-01)
Marketing Start Date	2016-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 52139708-8a21-4fc5-b375-c6f9064cce22 Details

Active ingredient

Docusate Calcium 240 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 notice 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 healthcare professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

Adults and Children over 12 years of age

Take orally 1 softgel daily for 2 to 3 days or until bowl 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

•: Keep lid tightly closed.
•: Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
•: Do not use if either seal is broken or missing.

Inactive Ingredients

Corn Oil, FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Ink (Edible), Sorbitol Special.

Questions or Comments

Call 1 (800) 682-9862

Package/Label Principal Display Panel

NDC 54629-0640-01

LIFE-LINE®

DOCUSATE

CALCIUM

SODIUM-FREE

STOOL SOFTENER

240 mg Each

100 Softgels

LIFE-LINE VITAMINS

U.S.A.

Since 1974

Manufactured and Distributed by

NATIONAL VITAMIN COMPANY

Casa Grande, AZ 85122

Label

INGREDIENTS AND APPEARANCE

DOCUSATE CALCIUM 240 MG SODIUM FREE

docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54629-640
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE CALCIUM	240 mg

Ingredient Name	Strength
Inactive Ingredients
CORN OIL (UNII: 8470G57WFM)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	NV02
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54629-640-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/01/2016

Labeler - National Vitamin Company (102098324)

Registrant - National Vitamin Company (102098324)

Name	Address	ID/FEI	Business Operations
Establishment
National Vitamin Company		102098324	MANUFACTURE(54629-640) , ANALYSIS(54629-640)

Revised: 4/2020

Document Id: f06f12d6-1c98-4027-87c7-1140a7740490

Set id: 52139708-8a21-4fc5-b375-c6f9064cce22

Version: 2

Effective Time: 20200410