Quality Choice 164.000/164aa Rev 2-164ab

Quality Choice 164.000/164aa Rev 2-164ab
SPL v20
SPL
SPL Set ID 629c5817-13b7-4527-8998-93131ee3529e
Route
ORAL
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1.745 g)
Inactive Ingredients
Citric Acid Monohydrate Edetate Disodium Anhydrous Sucralose Water Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-15

Description

Magnesium citrate 1.745g

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

Magnesium citrate 1.745g

Uses
  • for relief of occasional constipation (irregularity).
  • Generally produces bowel movement in 1/2 to 6 hours
Storage

Store at temperatures betweem 46° and 86°F (8° and 30° C)

Warnings

for this product

Directions
  • shake well before using
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours

children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz maximum 7 fl oz in 24 hours

children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

Disclaimer

Non-USP: Non-Carbonated, Non-Pasteurized; Contains Perservatives

100% QC SATISFACTION GUARANTEED

Adverse Reaaction

Disributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Information
  • each fl oz contains: magnesium 290 mg
  • each fl oz contains: sodium 1 mg
Inactive Ingredients

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Principal Display Panel

NDC: 63868-018-38

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

QC ®

QUALITY

CHOICE

Magnesium

Citrate

Saline Laxative

Oral Solution

For the Relief of Occasional Constipation

Cherry flavor

10 FL OZ (296 mL)

If Pregnant Or Breast Feeding

ask health professional before use.

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.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Fl Oz)

Magnesium citrate 1.745g

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).
  • Generally produces bowel movement in 1/2 to 6 hours
Purpose

Saline laxative

Storage

Store at temperatures betweem 46° and 86°F (8° and 30° C)

Warnings

for this product

Directions
  • shake well before using
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours

children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz maximum 7 fl oz in 24 hours

children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

Disclaimer

Non-USP: Non-Carbonated, Non-Pasteurized; Contains Perservatives

100% QC SATISFACTION GUARANTEED

Adverse Reaaction (Adverse reaaction)

Disributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Information (other information)
  • each fl oz contains: magnesium 290 mg
  • each fl oz contains: sodium 1 mg
Inactive Ingredients (Inactive ingredients)

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Principal Display Panel (Principal display panel)

NDC: 63868-018-38

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

QC ®

QUALITY

CHOICE

Magnesium

Citrate

Saline Laxative

Oral Solution

For the Relief of Occasional Constipation

Cherry flavor

10 FL OZ (296 mL)

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask health professional before use.

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.

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.

Active Ingredient (in Each Fl Oz) (Active Ingredient (in each fl oz))

Magnesium citrate 1.745g

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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