EPSOM SALTS- magnesium sulfate granule

Epsom Salts by

Drug Labeling and Warnings

Epsom Salts by is a Otc medication manufactured, distributed, or labeled by NEW PRIDE CORP, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Magnesium Sulfate (heptahydrate) 100% Saline Laxative

PURPOSE

Uses

• For relief of Occasional Constipation (Irregularity)
• This product generally produces bowel movement

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after any other drugs. Laxative may affect how other drugs work.

WARNINGS

Warnings

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 of longer than 1 week

If pregnant or breast-feeding ask a health profesional before use

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

There are no inactive ingredients

PRINCIPAL DISPLAY PANEL

Assured

Multipurpose

Epsom Salts

Net Wt. 16 oz (454 g)

INGREDIENTS AND APPEARANCE

EPSOM SALTS 
magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58037-008
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	100 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58037-008-01	454 g in 1 POUCH; Type 0: Not a Combination Product	07/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/09/2019

Labeler - NEW PRIDE CORP (884264198)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(58037-008)