ASSURED EPSOM SALT- magnesium sulfate granule

Assured Epsom Salt by

Drug Labeling and Warnings

Assured Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc.. 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 in 1/2 to 6 hours

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

If pregnant or bread feeding, aska a health professional before use. 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 your are taking any other drug. Take this product 2  or more hours before or after other drugs. Laxatives 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 longer than 1 week

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 year  - 1 to 2 level teaspoons (5 to 10 grams) daily

children under 6 year - consult a doctor

INACTIVE INGREDIENT

None Available

PRINCIPAL DISPLAY PANEL

Assured

Multi-Purpose

Epsom Salt

Natural Magnesium Sulfate

All Natural

Net WT 16 OZ (454g)

INGREDIENTS AND APPEARANCE

ASSURED EPSOM SALT 
magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-3020
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

Inactive Ingredients
Ingredient Name	Strength
SULFUR (UNII: 70FD1KFU70)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-3020-1	454 g in 1 BAG; Type 0: Not a Combination Product	06/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/14/2016

Labeler - Greenbrier International, Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
Greenbrier International, Inc.		529047265	manufacture(33992-3020)