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NDC 00363-0395-01 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 Walgreens. The primary component is MAGNESIUM SULFATE HEPTAHYDRATE.

Product Information

NDC	00363-0395
Product ID	0363-0395_adcab0d5-0551-4ce7-a2a4-94adef0972f8
Associated GPIs
GCN Sequence Number	001418
GCN Sequence Number Description	magnesium sulfate CRYSTALS 100 % MISCELL
HIC3	U6W
HIC3 Description	BULK CHEMICALS
GCN	04170
HICL Sequence Number	000610
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	GRANULE
Route	ORAL; TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/g
Substance Name	MAGNESIUM SULFATE HEPTAHYDRATE
Labeler Name	Walgreens
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 00363-0395-01 (00363039501)

Pricing Information	N/A
NDC Package Code	0363-0395-01
Billing NDC	00363039501
Package	454 g in 1 POUCH (0363-0395-01)
Marketing Start Date	2016-04-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7365e199-5038-48eb-b0b9-7b46f9894dd7 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 dissolved in a full glass (8oz) of water

Not recommended for children under 6 years of age.

Other information

each teaspoon contains: magnesium 495 mg

Inactive ingredient

none

Questions or comments?

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

Principal Display Panel

EPSOM SALTS

MAGNESIUM SULFATE USP

(HEPTAHYDRATE) 100%

Soaking aid for minor sprains & bruises
Saline laxative

NET WT LBS ( kg)

Tamper evident: do not use if the heat-sealed pouch is improperly sealed

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Package Label

Magnesium Sulfate (Heptahydrate) USP 100%

WALGREENS Epsom Salt

INGREDIENTS AND APPEARANCE

EPSOM SALT

magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0395
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:0363-0395-04	1810 g in 1 POUCH; Type 0: Not a Combination Product	04/30/2016
2	NDC:0363-0395-06	2721 g in 1 POUCH; Type 0: Not a Combination Product	04/30/2016
3	NDC:0363-0395-03	1360 g in 1 POUCH; Type 0: Not a Combination Product	04/30/2016
4	NDC:0363-0395-01	454 g in 1 POUCH; Type 0: Not a Combination Product	04/30/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	04/30/2016

Labeler - Walgreens (008965063)

Revised: 2/2022

Document Id: adcab0d5-0551-4ce7-a2a4-94adef0972f8

Set id: 7365e199-5038-48eb-b0b9-7b46f9894dd7

Version: 10

Effective Time: 20220204