EPSOM SALT- magnesium sulfate granule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)
Available from:
Strategic Sourcing Services LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
 Saline laxative - relieves occasional constipation (irregularity) - generally produces bowel movement in 1/2 to 6 hours
Authorization status:
OTC monograph not final
Authorization number:
62011-0362-1

EPSOM SALT- magnesium sulfate granule

Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Magnesium sulfate USP 100%

Purpos e

Saline laxative

Us es

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

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 493 mg

Inactive Ingredients

none

Questions or comments?

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

Principal Display Panel

SALINE LAXATIVE

Epsom Salt

Magnesium Sulfate

Most commonly used as an aid in soaking minor sprains & bruises

Saline laxative for the short-term relief of constipation

Net Wt OZ (lb) g

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

Another Quality Product

Distributed by McKesson

One Post Street, San Francisco, CA 94104

www.healthmart.com

Package Label

HEALTH MART Epsom Salt

EPSOM SALT

magnesium sulfate granule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 11-0 36 2

Route of Administration

ORAL, TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE0 8 0 37SAB) (MAGNESIUM CATION -

UNII:T6 V3LHY8 38 )

MAGNESIUM SULFATE,

UNSPECIFIED

1 g in 1 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 20 11-0 36 2-1

454 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 3/31/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part334

0 3/31/20 19

Strategic Sourcing Services LLC

Labeler -

Strategic Sourcing Services LLC (116956644)

Revised: 7/2020

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