Humco Epson Salt Powder, For Solution
FDA Label NDC 0395-0807

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc. for the product Humco Epson Salt (NDC 0395-0807). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, puropose, use, warnings, stop use and consult a doctor if, keep out of reach of children., directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Label 4 oz

Label 16 oz

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