FDA Label for Epsom Salts Relief

View Indications, Usage & Precautions

Epsom Salts Relief Product Label

The following document was submitted to the FDA by the labeler of this product Blue Cross Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients Purpose

Magnesium Sulfate [heptahydrate]100% Saline Laxative


Otc - Purpose



-For relief of occasional constipation (irregularity)

-this product generally produces bowel movement in 1/2 to 6 hours


Otc - Keep Out Of Reach Of Children



Keep out of reach of children


Indications & Usage



-For relief of occasional constipation (irregularity)

-this product generally produces bowel movement in 1/2 to 6 hours


Warnings



Warnings

Ask a doctor is 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 a doctor of 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.

If pregnant or breast-feeding, as a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

-do not exceed more than 2 doses per day

-drink a full glass (8 ounces) of liquid with each dose

-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 4 level teaspoons (10 to 20 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



Other information

Magnesium content: 495 mg per teaspoon


Package Label.Principal Display Panel



Relief

Epsom Salt

Magnesium Sulfate

A Soaking aid for minor sprains & bruises

Use as a saline laxative

NET WT 16 Oz (1 LB) 454 g


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