Epsom Salt — v3

Epsom Salt

9 Views

Version

v3

Effective date

September 23, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
3f7d0ab5-6266-9d1b-e063-6294a90abad0
Set ID
73065a04-b7cd-437d-9624-f845f5ec93bf
Application numbers
M007
Product NDCs
72036-602
Package NDCs
72036-602-01
Original packager NDCs

Names & Manufacturers

Brand names
Epsom Salt
Generic names
MAGNESIUM SULFATE
Manufacturer names
HARRIS TEETER
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
MAGNESIUM SULFATE HEPTAHYDRATE
Routes
ORAL, TOPICAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
1053346
UNII
SK47B8698T
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Magnesium sulfate USP (heptahydrate) 100%
Adverse Reactions (1)

Sequence 1

Adverse Reaction PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 1-800-432-6111 or harristeeter.com
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have kidney disease a magnesium-restricted diet abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks already used a laxative for a period longer than 1 week
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
Dosage And Administration (1)

Sequence 1

Directions do not exceed recommended daily dosage drink a full glass (8 ounces) of liquid with each dose may be taken as a single daily dose or in divided doses dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste. adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily children under 6 years - consult a doctor
Inactive Ingredient (1)

Sequence 1

Inactive Ingredients None
Indications And Usage (1)

Sequence 1

Uses for relief of occasional constipation (irregularity) for this product generally produces bowel movement in 1/2 to 6 hours
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other Safety Information (2)

Sequence 1

TEP Statement Tamper Evident Packaging Caution: This package has been sealed for your protection. Do not use if package is open, torn or mulitated

Sequence 2

Other information each teaspoon (5 grams) contains: magnesium 495 mg
Package Label Principal Display Panel (1)

Sequence 1

principal panel display Cut along dotted line and press zipper to reseal. Harris Teeter ™ EPSOM SALT MAGNESIUM SULFATE U.S.P. SALINE LAXATIVE For Relief of Occasional Constipation SOAKING AID For Minor Sprains and Bruises NET WT. 4 LB (1.81 kg) EPSOM SALT Magnesium Sulfate U.S.P. NET WT. 4 LB (1.81 kg) image description
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a help professional before use.
Purpose (1)

Sequence 1

Purpose Saline Laxative
Spl Product Data Elements (1)

Sequence 1

Epsom Salt Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE MAGNESIUM CATION
Spl Unclassified Section (1)

Sequence 1

Disclaimer FOR EXTERNAL USE AS A SOAKING AID FOR MINOR SPRAINS AND BRUISES. DIRECTIONS: For a relaxing bath/soak, generously sprinkle Epsom Salt into warm, running bath water. CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician. Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician. Keep out of reach of children.
Stop Use (1)

Sequence 1

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.
Warnings (1)

Sequence 1

Warnings for this product

OpenFDA raw payload

{'application_number': ['M007'],
 'brand_name': ['Epsom Salt'],
 'generic_name': ['MAGNESIUM SULFATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['HARRIS TEETER'],
 'package_ndc': ['72036-602-01'],
 'product_ndc': ['72036-602'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL', 'TOPICAL'],
 'rxcui': ['1053346'],
 'spl_id': ['3f7d0ab5-6266-9d1b-e063-6294a90abad0'],
 'spl_set_id': ['73065a04-b7cd-437d-9624-f845f5ec93bf'],
 'substance_name': ['MAGNESIUM SULFATE HEPTAHYDRATE'],
 'unii': ['SK47B8698T']}