EPSOM SALT- magnesium sulfate granule, for solution

Epsom Salt by

Drug Labeling and Warnings

Epsom Salt by is a Otc medication manufactured, distributed, or labeled by C.D.M.A., Consumer Product Partners, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Tamper Evident Statement

TAMPER EVIDENT PACKAGING:

CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION.

DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED.

Active ingredient

Magnesium sulfate USP (Heptahydrate) 100%

Purpose

Saline laxative

Uses

• for relief of occasional constipation (irregularity)
• this product generally produces bowel movement in 1/2 to 6 hours

Warnings

for this product

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 or 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.

Stop use and ask a doctor

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding

ask 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.

Directions

• do not exceed recommended daily dosage
• drink a full glass (8 ounces) of liquid with each dose
• may be taken as a single daily dose or in divided doses
• 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 6 level teaspoons (10 to 30 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

Other information

• each teaspoon (5 grams) contains: magnesium 495 mg

Inactive ingredient

None

Claims

Epsom Salt

Saline Laxitive

Magnesium Sulfate U.S.P.

MgSO 4  7H 2O

For external use as a soaking for minor sprains and bruises.

Directions: For a relaxing bath/soak, generously sprinkle Epsom Salt into warm, running bath water.

CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician. Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician. Keep out of reach of children.

Adverse reaction

SATISFACTION GUARANTEED

100% QC

Distributed By:CDMA, Inc.

Novi, MI 48375

www. qualitychoice.com

Questions: 800-935-2362

Principal display panel

Cut along dotted line and press zipper to reseal.

NDC: 83324-175-16

QC ®

QUALITY

CHOICE

Epsom

Salt

Saline Laxative

Magnesium Sulfate U.S.P.

MgSO 4   7H 2O

Saline Laxative

For Relief of Occasional Constipation

Soaking Aid

For Minor Sprains and Bruises

NET WT 1 LB (454 g)

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-175
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-175-16	454 g in 1 POUCH; Type 0: Not a Combination Product	07/02/2024
2	NDC: 83324-175-04	1814 g in 1 POUCH; Type 0: Not a Combination Product	07/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	07/02/2024

Labeler - C.D.M.A. (011920774)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(83324-175)