Natural Epsom Salt 

Natural Epsom Salt 
SPL v1
SPL
SPL Set ID b2682e51-ffa4-4556-b2a6-b0dbd543fd4f
Route
ORAL
Published
Effective Date 2024-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (100 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

Magnesium Sulfate USP 100%

Purpose

Internal Use.............................................Saline Laxative External Use...........................................Soaking Solution


Medication Information

Warnings and Precautions

WARNINGS - Consult a doctor before use if you have:

• kidney disease

• a magnesium restricted diet

• stomach pain, nausea or vomiting

• noticed a sudden change in bowel habits that continues more than 2 weeks

• already used a laxative for more than 1 week

Consult a doctor or pharmacist before using if you are taking any other prescription drugs.

Laxatives may affect how other drugs work.

When using this product, DO NOT USE more than directed.

Stop use and consult a doctor if:

As Laxative:

• you have rectal bleeding or failure to have a bowel movement after use

• you need to use a laxative for more than 1 week

As soaking solution:

• you have redness, irritation, swelling, or infection occurs

• do not use hot or warm soaks individuals with diabetes without consulting a doctor

If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

INTERNAL USE

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 1/2 to 6 hours

EXTERNAL USE

• Relieves pain from minor sprains and bruises

Purpose

Internal Use.............................................Saline Laxative

External Use...........................................Soaking Solution

Description

Magnesium Sulfate USP 100%

Section 42229-5

UNSCENTED EPSOM SALT IS FOR INTERNAL AND EXTERNAL USE. SCENTED EPSOM SALTS ARE FOR EXTERNAL USE ONLY.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51727-6

None

Packaging

Directions

 • do not exceed more than 2 doses per day

 Age  Dose
adults and children 12 years and older 2 to 4 level teaspoons(10 to 20 grams) dissolved in a full glass (8oz) of water
children 6 to under 12 years 1 to 2 level teaspoons(5 to 10 grams) dissolved in a full glass (8oz) of water

Not recommended for children under 6 years of age.

Drug Facts

Active Ingredient

Magnesium Sulfate USP 100%


Structured Label Content

Indications and Usage (34067-9)

INTERNAL USE

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 1/2 to 6 hours

EXTERNAL USE

• Relieves pain from minor sprains and bruises

Warnings and Precautions (34071-1)

WARNINGS - Consult a doctor before use if you have:

• kidney disease

• a magnesium restricted diet

• stomach pain, nausea or vomiting

• noticed a sudden change in bowel habits that continues more than 2 weeks

• already used a laxative for more than 1 week

Consult a doctor or pharmacist before using if you are taking any other prescription drugs.

Laxatives may affect how other drugs work.

When using this product, DO NOT USE more than directed.

Stop use and consult a doctor if:

As Laxative:

• you have rectal bleeding or failure to have a bowel movement after use

• you need to use a laxative for more than 1 week

As soaking solution:

• you have redness, irritation, swelling, or infection occurs

• do not use hot or warm soaks individuals with diabetes without consulting a doctor

If pregnant or breast-feeding, ask a health professional before use.

Section 42229-5 (42229-5)

UNSCENTED EPSOM SALT IS FOR INTERNAL AND EXTERNAL USE. SCENTED EPSOM SALTS ARE FOR EXTERNAL USE ONLY.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51727-6 (51727-6)

None

Purpose

Internal Use.............................................Saline Laxative

External Use...........................................Soaking Solution

Packaging

Directions (DIRECTIONS)

 • do not exceed more than 2 doses per day

 Age  Dose
adults and children 12 years and older 2 to 4 level teaspoons(10 to 20 grams) dissolved in a full glass (8oz) of water
children 6 to under 12 years 1 to 2 level teaspoons(5 to 10 grams) dissolved in a full glass (8oz) of water

Not recommended for children under 6 years of age.

Drug Facts (DRUG FACTS)

Active Ingredient

Magnesium Sulfate USP 100%


Advanced Ingredient Data


Raw Label Data

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