Care One 602

Care One 602
SPL v2
SPL
SPL Set ID f2a8c16e-ea6c-4b71-8871-5fcf910df053
Routes
ORAL TOPICAL
Published
Effective Date 2015-05-15
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 Completed Since 2015-05-06 Until 2016-03-15

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 External use soaking aid

Adverse Reactions

DISTRIBUTED BY: FOODHOLD U.S.A., LLC LANDOVER, MD 20785 Quality Guaranteed or your money back.


Medication Information

Purpose

Saline Laxative

External use soaking aid

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Quality Guaranteed or your money back.

Description

Tamper Evident Packaging: Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilated

Tep

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

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

Claims

Epsom Salt

Magnesium Sulfate U.S.P.

M gSO 4 - 7H 2O

Warnings

CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.

Hot or warms soaks should not be used by individuals with diabetes except on the advice of a physican

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

Directions for Soaking:

Dissolve 2 cups of CareOne Epsom Salt per fallon of water.  Apply with bandages or toweling for 30 minutes up to three times a day.  For less intensive soak, use 1 or 2 cups in a bath.  Use warm water for best results

Active Ingredient

Magnesium sulfate USP (heptahydrate) 100%

Other Information
  • magnesium content 495 mg per teaspoon (5 grams)
Principal Display Panel

CAREONE

EPSOM

SALKT

MAGNESIUM SULFATE U.S.P.

  • SALINE LAXATIVE
  • SOAKING AID

For relief of occasional constipation

For minor sprains and bruises

NET WT 16 OZ

(1 LB) 454 g

Inactive Ingredient Section

None

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

Tep (TEP)

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

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

Claims

Epsom Salt

Magnesium Sulfate U.S.P.

M gSO 4 - 7H 2O

Purpose

Saline Laxative

External use soaking aid

Warnings

CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.

Hot or warms soaks should not be used by individuals with diabetes except on the advice of a physican

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

Directions for Soaking:

Dissolve 2 cups of CareOne Epsom Salt per fallon of water.  Apply with bandages or toweling for 30 minutes up to three times a day.  For less intensive soak, use 1 or 2 cups in a bath.  Use warm water for best results

Active Ingredient (Active ingredient)

Magnesium sulfate USP (heptahydrate) 100%

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Quality Guaranteed or your money back.

Other Information (Other information)
  • magnesium content 495 mg per teaspoon (5 grams)
Principal Display Panel (principal display panel)

CAREONE

EPSOM

SALKT

MAGNESIUM SULFATE U.S.P.

  • SALINE LAXATIVE
  • SOAKING AID

For relief of occasional constipation

For minor sprains and bruises

NET WT 16 OZ

(1 LB) 454 g

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

None

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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