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

Active Ingredient

Active ingredient                                     Purpose

Magnesium Sulfate USP (Epsom Salts)     

External use                                          Soaking solution

Internal Use                                           Saline Laxative     

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.


Structured Label Content

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

Active Ingredient (55106-9)

Active ingredient                                     Purpose

Magnesium Sulfate USP (Epsom Salts)     

External use                                          Soaking solution

Internal Use                                           Saline Laxative     

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

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.


Advanced Ingredient Data


Raw Label Data

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