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NDC 11822-4454-03 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 Rite Aid Corporation. The primary component is MAGNESIUM SULFATE, UNSPECIFIED.

Product Information

NDC	11822-4454
Product ID	11822-4454_9c3ac842-319b-4129-b37f-635666fd14b0
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	Epsom Salt
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	Rite Aid Corporation
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 11822-4454-03 (11822445403)

Pricing Information	N/A
NDC Package Code	11822-4454-3
Billing NDC	11822445403
Package	2722 g in 1 POUCH (11822-4454-3)
Marketing Start Date	2021-05-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 346296eb-4ab9-4853-8bb3-2f9a00b6e629 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

MAGNESIUM SULFATE

EPSOM SALTS

MULTI-PURPOSE

Soaking solution

Saline laxative

Soaking Aid For Minor Sprains and Bruises

Relieves occasional constipation

Net Wt OZ LB (kg)

TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

Package Label

RITE AID Epsom Salt

INGREDIENTS AND APPEARANCE

EPSOM SALT

epsom salt granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-4454
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:11822-4454-3	2722 g in 1 POUCH; Type 0: Not a Combination Product	05/28/2021
2	NDC:11822-4454-1	1361 g in 1 POUCH; Type 0: Not a Combination Product	05/28/2021
3	NDC:11822-4454-2	545 g in 1 POUCH; Type 0: Not a Combination Product	05/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/28/2021

Labeler - Rite Aid Corporation (014578892)

Revised: 1/2022

Document Id: 9c3ac842-319b-4129-b37f-635666fd14b0

Set id: 346296eb-4ab9-4853-8bb3-2f9a00b6e629

Version: 2

Effective Time: 20220104