Quality Choice 602.002/602aa

Quality Choice 602.002/602aa
SPL v4
SPL
SPL Set ID 4ee26633-8eb1-4c68-a768-20460404533a
Routes
ORAL TOPICAL
Published
Effective Date 2025-03-13
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 2024-07-02

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
Claims

Epsom Salt

Saline Laxitive

Magnesium Sulfate U.S.P.

MgSO • 7H 2O

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

Directions: For a relaxing bath/soak, generously sprinkle 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.

Warnings

for this product

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

Adverse Reaction

SATISFACTION GUARANTEED

100% QC

Distributed By:CDMA, Inc.

Novi, MI 48375

www. qualitychoice.com

Questions: 800-935-2362

Active Ingredient

Magnesium sulfate USP (Heptahydrate) 100%

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

None

Principal Display Panel

Cut along dotted line and press zipper to reseal.

NDC 83324-175-16

QC ®

QUALITY

CHOICE

Epsom

Salt

Saline Laxative

Magnesium Sulfate U.S.P.

MgSO 4  • 7H 2O

Saline Laxative

For Relief of Occasional Constipation

Soaking Aid

For Minor Sprains and Bruises

NET WT 1 LB (454 g)

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

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
Claims

Epsom Salt

Saline Laxitive

Magnesium Sulfate U.S.P.

MgSO • 7H 2O

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

Directions: For a relaxing bath/soak, generously sprinkle 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.

Purpose

Saline laxative

Warnings

for this product

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

Adverse Reaction (Adverse reaction)

SATISFACTION GUARANTEED

100% QC

Distributed By:CDMA, Inc.

Novi, MI 48375

www. qualitychoice.com

Questions: 800-935-2362

Active Ingredient (Active ingredient)

Magnesium sulfate USP (Heptahydrate) 100%

Other Information (Other information)
  • each teaspoon (5 grams) contains: magnesium 495 mg
Inactive Ingredient (Inactive ingredient)

None

Principal Display Panel (Principal display panel)

Cut along dotted line and press zipper to reseal.

NDC 83324-175-16

QC ®

QUALITY

CHOICE

Epsom

Salt

Saline Laxative

Magnesium Sulfate U.S.P.

MgSO 4  • 7H 2O

Saline Laxative

For Relief of Occasional Constipation

Soaking Aid

For Minor Sprains and Bruises

NET WT 1 LB (454 g)

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 (Stop use and ask a doctor)

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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