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NDC 68196-0395-07 Epsom Salt 1 g/g Details

Epsom Salt 1 g/g

Epsom Salt is a ORAL; TOPICAL GRANULE in the HUMAN OTC DRUG category. It is labeled and distributed by Sam's West, Inc. The primary component is MAGNESIUM SULFATE, UNSPECIFIED.

Product Information

NDC	68196-0395
Product ID	68196-395_1b41f11a-4cb9-4edd-b86f-5a1cf4f5bcd2
Associated GPIs
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	Epsom Salt
Proprietary Name Suffix	n/a
Non-Proprietary Name	Magnesium sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	GRANULE
Route	ORAL; TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/g
Substance Name	MAGNESIUM SULFATE, UNSPECIFIED
Labeler Name	Sam's West, Inc
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 68196-0395-07 (68196039507)

Pricing Information	N/A
NDC Package Code	68196-395-07
Billing NDC	68196039507
Package	3175 g in 1 POUCH (68196-395-07)
Marketing Start Date	2019-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6edb7688-0a64-4a7e-a0c0-9f75c96682fe Details

Active ingredient

Magnesium sulfate USP 100%

Purpose

Saline laxative

Uses

relieves occasional constipation (irregularity)
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
stomach pain, nausea or vomiting
noticed a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug.

When using this product

do not use more than directed

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
you need to use a laxative for more than 1 week

If pregnancy 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 (1-800-222-1222) right away.

Directions

do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours

age	dose
adults and children 12 years and older	2-4 level teaspoons dissolved in a full glass (8oz) of water
children 6 to 11 years	1-2 level teaspoons in a full glass (8oz) of water

Not recommended for children under 6 years of age.

Inactive Ingredients

None

Other information

each teaspoon contains: magnesium 495 mg

Questions or comments?

For laxative or soak, call toll free 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

EPSOM SALTS

Magnesium Sulfate USP

Saline Laxative

for relief of occasional constipation

Plant food supplement

for bigger, more vigorous plant

Soaking Solution

for minor sprains, bruises & mineral bath

NET WT OZ ( LBS)

DISTRIBUTED BY

SAM'S WEST, AR 72716

Package Label

MEMBER'S MARK Epsom Salt

INGREDIENTS AND APPEARANCE

EPSOM SALT

magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68196-395
Route of Administration	ORAL, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68196-395-14	2 in 1 PACKAGE, COMBINATION	02/28/2019
1		3175 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:68196-395-07	3175 g in 1 POUCH; Type 0: Not a Combination Product	02/28/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/28/2019

Labeler - Sam's West, Inc (051957769)

Revised: 2/2022

Document Id: 1b41f11a-4cb9-4edd-b86f-5a1cf4f5bcd2

Set id: 6edb7688-0a64-4a7e-a0c0-9f75c96682fe

Version: 4

Effective Time: 20220208