RELIEF EPSOM SALT- magnesium sulfate heptahydrate granule

Relief Epsom Salt by

Drug Labeling and Warnings

Relief Epsom Salt by is a Otc medication manufactured, distributed, or labeled by BLUE CROSS LABORATORIES, INC., Hefei Yatai Daily Chemical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients  Purpose

Magnesium Sulfate [heptahydrate]100%          Saline Laxative

PURPOSE

-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

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 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

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

PRINCIPAL DISPLAY PANEL

Relief

Epsom Salt

Magnesium Sulfate

• Use as a soaking solution for minor aches & sprains

• Use as a saline laxative
• Great For Gardening

NET WT  8 LB (3.63kg)

INGREDIENTS AND APPEARANCE

RELIEF EPSOM SALT 
magnesium sulfate heptahydrate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22431-248
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	3.63 kg  in 3.63 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22431-248-01	3.63 kg in 1 BAG; Type 0: Not a Combination Product	08/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/22/2017

Labeler - BLUE CROSS LABORATORIES, INC. (008298879)

Registrant - BLUE CROSS LABORATORIES, INC. (008298879)

Establishment
Name	Address	ID/FEI	Business Operations
Hefei Yatai Daily Chemical Products Co., Ltd.		654641724	manufacture(22431-248)