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NDC 70677-0038-02 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 Strategic Sourcing Services LLC. The primary component is MAGNESIUM SULFATE, UNSPECIFIED.

Product Information

NDC	70677-0038
Product ID	70677-0038_f070af44-13fb-47b0-845c-35284acf4378
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	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	Strategic Sourcing Services LLC
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 70677-0038-02 (70677003802)

Pricing Information	N/A
NDC Package Code	70677-0038-2
Billing NDC	70677003802
Package	1814 g in 1 POUCH (70677-0038-2)
Marketing Start Date	2017-12-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1515fadd-a7a5-4502-afe2-cfcd50d5bfc8 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
store in a cool dry place out of direct sunlight

Inactive ingredient

none

Questions or comments?

For laxative or soak, call 1-833-358-6431 Monday- Friday 9AM-7PM EST

Principal Display Panel

Epsom salt

Magnesium Sulfate

Multi use product

Most commonly used as an aid

in soaking minor sprains & bruises

Saline laxative for the short term relief of constipation

SALINE LAXATIVE

Net Wt LB (kg)

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

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

Package Label

SUNMARK Epsom Salt

INGREDIENTS AND APPEARANCE

EPSOM SALT

epsom salt granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0038
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:70677-0038-2	1814 g in 1 POUCH; Type 0: Not a Combination Product	12/31/2017
2	NDC:70677-0038-1	454 g in 1 POUCH; Type 0: Not a Combination Product	12/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/31/2017

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 3/2022

Document Id: f070af44-13fb-47b0-845c-35284acf4378

Set id: 1515fadd-a7a5-4502-afe2-cfcd50d5bfc8

Version: 5

Effective Time: 20220303