HUMCO EPSON SALT- magnesium sulfate powder, for solution

Humco Epson Salt by

Drug Labeling and Warnings

Humco Epson Salt by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Magnesium Sulfate (heptahydrate) 100%

Puropose

Laxative/Soak solution

Use

As a laxative: For relief of occasional constipation.

As an external soaking aid: For temporary relief of minor sprains and bruises.

Warnings

Ask as a doctor before use if you:

haeve kidney disease or diabetes. Have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks. Have already used a laxative for a period longer than 1 week.

Serious side effects from prolonged use or overdose may occur.

Are taking prescription drugs.

Stop use and consult a doctor if

When taking as laxative, there is rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

When using as soaking aid, discontinue use where promt relief is not obtained or where there is evidence of infection. Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician.

If pregnant or breasfeeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek preofessional assistance or contact Poison Control Center immediately.

Directions

For laxative use. Adults and children 12 yrs. of age and older:  2 to 4 level tsps (10 - 30 g) in an 8 oz glass of water. Repeat in 6 hours if needed. Drink 8 ozs of liquid with each dose. limit 2 doses per day. Lemon juice may be added to improve taste. this product generally produces bowel movements in 1/2 to 6 hours. Best when taken on an empty stomach.

Children 6 to 12 yrs of age: Consulta doctor before use.

For use as a soaking aid: Dissolve 2 cupfuls of Epson Salt per gallon of warm water. apply in conjunction with bandages or toweling.

Inactive ingredient

None

Principal display panel

INGREDIENTS AND APPEARANCE

HUMCO EPSON SALT 
magnesium sulfate powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-0807
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	1000 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-0807-94	113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017
2	NDC: 0395-0807-16	454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/25/1998

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-0807) , analysis(0395-0807) , pack(0395-0807) , label(0395-0807)