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NDC 70000-0021-02 Epsom Salt 1 g/g Details

Epsom Salt 1 g/g

Epsom Salt is a ORAL; TOPICAL CRYSTAL in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba Leader. The primary component is MAGNESIUM SULFATE HEPTAHYDRATE.

Product Information

NDC	70000-0021
Product ID	70000-0021_c61d2ec2-9f0a-47ee-b087-6a1854d0f3a0
Associated GPIs	46100030102750
GCN Sequence Number	003022
GCN Sequence Number Description	magnesium sulfate GRANULES 495 MG/5 G ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09200
HICL Sequence Number	001327
HICL Sequence Number Description	MAGNESIUM SULFATE
Brand/Generic	Generic
Proprietary Name	Epsom Salt
Proprietary Name Suffix	n/a
Non-Proprietary Name	MAGNESIUM SULFATE
Product Type	HUMAN OTC DRUG
Dosage Form	CRYSTAL
Route	ORAL; TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/g
Substance Name	MAGNESIUM SULFATE HEPTAHYDRATE
Labeler Name	Cardinal Health, 110 dba Leader
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0021-02 (70000002102)

Pricing Information
NDC Package Code	70000-0021-2
Billing NDC	70000002102
Package	1814 g in 1 POUCH (70000-0021-2)
Marketing Start Date	2012-03-26
NDC Exclude Flag	N
Price Per Unit	0.00243
Pricing Unit	GM
Effective Date	2023-02-22
NDC Description	EPSOM SALT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-14

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 d27dc1cc-5e17-40d3-84fe-c1792552cfd5 Details

SAFETY SEAL

TAMPER EVIDENT PACKAGING:

CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION.

DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED

Active ingredient

Magnesium sulfate USP (heptahydrate)100%

Purpose

Saline Laxative

Uses

Uses for Oral Laxative

for relief of occasional constipation (irregularity)
this product generally produces bowel movement in 1/2 to 6 hours

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium-restricted diet
abdominal pain, nausea, or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks
already used a laxative for a period longer than 1 week

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product 2 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 failure to have a bowel movement after use. These could be signs of a serious condition.

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

do not exceed recommended daily dosage
drink a full glass (8 ounces) of liquid with each dose
may be taken as a single daily dose or in divided doses
dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.

adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily

children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily

children under 6 years - consult a doctor

Other information

each teaspoon (5 grams) contains: magnesium 495 mg

claims

For external use as a soaking aid for minor sprains and bruises.

Directions: {For a relaxing bath/soak,} generously {or liberally} sprinkle {or pour} LEADER Epsom Salt into warm, running bath water

Caution: IF PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENE OF INFECITION, DISCONTINUE USE AND CONSULT YOUR PHYSICIAN. HOT OR WARM SOAKS SHOULD NOT BE USED BY INDIVIDUALS WITH DIABETES EXCEPT ON THE ADVICE OF A PHYSICIAN. KEEP OUT OF REACH OF CHILDREN.

Inactive Ingredients

None

Question and comments?

1-800-593-0593

Adverse reactions section

Cardinal Health

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1800-200-6313

Essential to Care since 1979

ALL LEADER Brand Product Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied

CIN 5516083 REV 4/19

principal display panel

CUT ALONG DOTTED LINE AND PRESS ZIPPER TO RESEAL

LEADER

NDC 70000-0021-1

EPSOM

SALT

Magnesium Sulfate USP, 100%

Saline Laxative

Saine Laxative

For Relief of Occasional

Constipation

Soaking Aid

For Minor Sprains

and Bruises

100% Money

Back Guarantee

Net WT 1 LB (454 g)

INGREDIENTS AND APPEARANCE

EPSOM SALT

magnesium sulfate crystal

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0021
Route of Administration	ORAL, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0021-2	1814 g in 1 POUCH; Type 0: Not a Combination Product	03/26/2012
2	NDC:70000-0021-1	454 g in 1 POUCH; Type 0: Not a Combination Product	03/26/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/26/2012

Labeler - Cardinal Health, 110 dba Leader (063997360)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(70000-0021)

Revised: 11/2022

Document Id: c61d2ec2-9f0a-47ee-b087-6a1854d0f3a0

Set id: d27dc1cc-5e17-40d3-84fe-c1792552cfd5

Version: 12

Effective Time: 20221110