Top Care 029.003/029aa

Top Care 029.003/029aa
SPL v13
SPL
SPL Set ID b2ec06b3-647d-49ab-a392-6db63d96d1e3
Routes
ORAL TOPICAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-01

Description

TAMPER EVIDENT PACKAGING: CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION. DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED.

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

TAMPER EVIDENT PACKAGING: CAUTION: THIS PACKAGE HAS BEEN SEALED FOR YOUR PROTECTION. DO NOT USE IF PACKAGE IS OPEN, TORN OR MUTILATED.

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

for this product

Questions?

1-888-423-0139

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

Side Panels

TopCare Health

Epsom Salt

MAGNESIUM SULFATE U.S.P.

MgS0 4• 7H 20

  • Soaking Aid for Minor Sprains and Bruises
  • Plant Food Supplement for Bigger, More Vigorous Plants
  • Saline Laxative for Relief of Occasional Constipation

SOAKING SOLUTION

For external use as a soaking aid for minor sprains and bruises. Discover the relaxing spa like qualities of this product in your bath.

DIRECTIONS: For a relaxing bath/soak, generously sprinkle TopCare 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.

BEAT WINTER BLUES

Simply dissolve two cups of epsom salt in a warm bath:

• for a calm and refreshing soak

• to warm and relax your muscles

A MINERAL SPRING SPA

Springtime is your fresh start to working out, often leading to overexertion. Just dissolve two cups of epsom salt in warm bath water, settle in and experience the relief and relaxation.

SOAK IN SUMMER SALTS

Summertime is filled with fun outdoor activities like hiking, playing sports, gardening in your backyard and more. Dissolve two cups of epsom salt in warm bath water to soothe away your muscle aches and pains that summer fun activities can bring.

RELAX INTO AUTUMN

By dissolving two cups of epsom salt in a warm bath, you'll be able to:

• revitalize tired and aching muscles

• feel refreshed and rejuvenated

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

Itasca, IL 60143

©TOPCO VIJA0125

Questions? 1-888-423-0139

topcare@topco@com

www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

QUALITY GUARANTEED

This TopCare product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Active Ingredient

Magnesium sulfate USP ( Heptahydrate) 100%

Other Information
  • each teaspoon (5 grams) contains: magnesium content 495 mg
Inactive Ingredients

None

Principal Display Panel

Resealable Pouch

NDC 76162-029-80

TopCare ®health

Epsom Salt

MAGNESIUM SULFATE U.S.P.

MgS0 4• 7H 20

  • Soaking Aid for Minor Sprains and Bruises
  • Plant Food Supplement for bigger, More Vigorous Plants
  • Saline Laxative for Relief of Occasional Constipation

NEW WT 8 LB (3.63 kg)

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.

Stop Use and Ask A Doctor If

 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.

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.


Structured Label Content

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

Saline laxative

Warnings

for this product

Questions?

1-888-423-0139

Directions (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

Side Panels (Side panels)

TopCare Health

Epsom Salt

MAGNESIUM SULFATE U.S.P.

MgS0 4• 7H 20

  • Soaking Aid for Minor Sprains and Bruises
  • Plant Food Supplement for Bigger, More Vigorous Plants
  • Saline Laxative for Relief of Occasional Constipation

SOAKING SOLUTION

For external use as a soaking aid for minor sprains and bruises. Discover the relaxing spa like qualities of this product in your bath.

DIRECTIONS: For a relaxing bath/soak, generously sprinkle TopCare 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.

BEAT WINTER BLUES

Simply dissolve two cups of epsom salt in a warm bath:

• for a calm and refreshing soak

• to warm and relax your muscles

A MINERAL SPRING SPA

Springtime is your fresh start to working out, often leading to overexertion. Just dissolve two cups of epsom salt in warm bath water, settle in and experience the relief and relaxation.

SOAK IN SUMMER SALTS

Summertime is filled with fun outdoor activities like hiking, playing sports, gardening in your backyard and more. Dissolve two cups of epsom salt in warm bath water to soothe away your muscle aches and pains that summer fun activities can bring.

RELAX INTO AUTUMN

By dissolving two cups of epsom salt in a warm bath, you'll be able to:

• revitalize tired and aching muscles

• feel refreshed and rejuvenated

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

Itasca, IL 60143

©TOPCO VIJA0125

Questions? 1-888-423-0139

topcare@topco@com

www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

QUALITY GUARANTEED

This TopCare product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Active Ingredient (Active ingredient)

Magnesium sulfate USP ( Heptahydrate) 100%

Other Information (Other information)
  • each teaspoon (5 grams) contains: magnesium content 495 mg
Inactive Ingredients (inactive ingredients)

None

Principal Display Panel (principal display panel)

Resealable Pouch

NDC 76162-029-80

TopCare ®health

Epsom Salt

MAGNESIUM SULFATE U.S.P.

MgS0 4• 7H 20

  • Soaking Aid for Minor Sprains and Bruises
  • Plant Food Supplement for bigger, More Vigorous Plants
  • Saline Laxative for Relief of Occasional Constipation

NEW WT 8 LB (3.63 kg)

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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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 (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.


Advanced Ingredient Data


Raw Label Data

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