Dr. Teals Magnesium Sulfate U.s.p.

Dr. Teals Magnesium Sulfate U.s.p.
SPL v1
SPL
SPL Set ID c93e2a1d-0fc4-4dc7-b253-9a9fe1a62151
Route
TOPICAL
Published
Effective Date 2012-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (2.72 kg)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-06-13

Description

Active ingredient                                     Purpose Magnesium Sulfate USP (Epsom Salts)      External use                                          Soaking solution Internal Use                                           Saline Laxative     


Medication Information

Warnings and Precautions

Warnings:

Laxative

- Do not give to children under six years of age except under the advice and supervision of a physician.

- For occasional use only. Serious side effects from prolonged use or overdose may occur.



Do not take this product except under the advice and supervision of a physician if you:

- Have kidney disease

- Are taking prescription medication

- Have a magnesium restricted diet



Ask a doctor before if you have



As a soaking solution

- redness or swelling present

- evidence of an infection

- diabetes - hot and warm soaks should not be used by individuals with diabetes except on advice of a physician



As a laxative

- Stomach pain

- Nausea

- Kidney disease

- A sudden change in bowel habits that lasts over 2 weeks



If pregnant or breast feeding, consult a physician before use



Other information

Dissolve before use

Indications and Usage

When using this product, do not use more than directed.

Stop use and consult a doctor if:

As a soaking solution

- you experience redness, irritation, swelling , or infection

As a laxative

- you have no bowel movements within six hours or experience rectal bleeding-these could be signs of a serious condition

- you need a laxative for more than a week

Dosage and Administration

Directions

- Do not exceed more than 2 doses per day, if neccessary repeat dosage in 4 hours

For External use

As a soaking solution: pour 2 cups of Epsom Salts under warm, running bath water. Soak for 20 minutes for to relieve sore,tired muscles.

As a warm compress: Dissolve 1 cup of Epsom Salts in 1 quart of warm water. Using a towel, apply solution to the affected area for 15-30  minutes to reduce pain and and swelling. Repeat as needed.





For internal use



As a laxative                                             2-4 level teaspoons dissolved in a full glass (8oz) of water.

adults and children 12 years and older



children 6 to 12 years of age                      1-2 level teaspoons dissolved in a full glass (8oz) of water.



not recommended for children under 6 years of age

Description

Active ingredient                                     Purpose Magnesium Sulfate USP (Epsom Salts)      External use                                          Soaking solution Internal Use                                           Saline Laxative     

Section 50565-1

Keep out of reach of children. In case of accidental ingestion or overdose, seek medical attention or contact a Poison Control Center immediately.

Section 51727-6

This product contains no inactive ingredients

















Section 51945-4

Dr. Teal's



Therapeutic solutions



Epsom Salt Soaking Solution



Magnesium Sulfate USP



Sooths aches, pains, sprains and stings



Helps relieve muscle tension



Made in U.S.A. with pure Epsom Salt





Net Wt. 2.72 Kg   6 lbs













Section 55105-1

Uses

External: Relieves pain from minor sprains and bruises

Internal: Relieves occasional constipation (irregularity)

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

Section 55106-9

Active ingredient                                     Purpose

Magnesium Sulfate USP (Epsom Salts)     

External use                                          Soaking solution

Internal Use                                           Saline Laxative     


Structured Label Content

Indications and Usage (34067-9)

When using this product, do not use more than directed.

Stop use and consult a doctor if:

As a soaking solution

- you experience redness, irritation, swelling , or infection

As a laxative

- you have no bowel movements within six hours or experience rectal bleeding-these could be signs of a serious condition

- you need a laxative for more than a week

Dosage and Administration (34068-7)

Directions

- Do not exceed more than 2 doses per day, if neccessary repeat dosage in 4 hours

For External use

As a soaking solution: pour 2 cups of Epsom Salts under warm, running bath water. Soak for 20 minutes for to relieve sore,tired muscles.

As a warm compress: Dissolve 1 cup of Epsom Salts in 1 quart of warm water. Using a towel, apply solution to the affected area for 15-30  minutes to reduce pain and and swelling. Repeat as needed.





For internal use



As a laxative                                             2-4 level teaspoons dissolved in a full glass (8oz) of water.

adults and children 12 years and older



children 6 to 12 years of age                      1-2 level teaspoons dissolved in a full glass (8oz) of water.



not recommended for children under 6 years of age

Warnings and Precautions (34071-1)

Warnings:

Laxative

- Do not give to children under six years of age except under the advice and supervision of a physician.

- For occasional use only. Serious side effects from prolonged use or overdose may occur.



Do not take this product except under the advice and supervision of a physician if you:

- Have kidney disease

- Are taking prescription medication

- Have a magnesium restricted diet



Ask a doctor before if you have



As a soaking solution

- redness or swelling present

- evidence of an infection

- diabetes - hot and warm soaks should not be used by individuals with diabetes except on advice of a physician



As a laxative

- Stomach pain

- Nausea

- Kidney disease

- A sudden change in bowel habits that lasts over 2 weeks



If pregnant or breast feeding, consult a physician before use



Other information

Dissolve before use

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion or overdose, seek medical attention or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

This product contains no inactive ingredients

















Section 51945-4 (51945-4)

Dr. Teal's



Therapeutic solutions



Epsom Salt Soaking Solution



Magnesium Sulfate USP



Sooths aches, pains, sprains and stings



Helps relieve muscle tension



Made in U.S.A. with pure Epsom Salt





Net Wt. 2.72 Kg   6 lbs













Section 55105-1 (55105-1)

Uses

External: Relieves pain from minor sprains and bruises

Internal: Relieves occasional constipation (irregularity)

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

Section 55106-9 (55106-9)

Active ingredient                                     Purpose

Magnesium Sulfate USP (Epsom Salts)     

External use                                          Soaking solution

Internal Use                                           Saline Laxative     


Advanced Ingredient Data


Raw Label Data

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