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  5. Label Information: Magnesium Citrate

FDA Label for Magnesium Citrate

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - ASK DOCTOR/PHARMACIST
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Magnesium Citrate Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredientMagnesium citrate 1.745 g per fl oz

Otc - Purpose



PurposeSaline Laxative

Indications & Usage



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

Warnings



Warnings

Otc - Ask Doctor



Ask a doctor before use if you have•kidney disease•a magnesium or potassium-restricted diet•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•

Otc - Ask Doctor/Pharmacist



Ask a doctor or a pharmacist before use if you are taking any other drug.  Take this product 2 or moremore hours before  or after other drugs.  Laxatives may affect how other drugs work.

Otc - Stop Use



Stop use and ask a doctor if you have rectal bleeding or failure to have a bowelmovement after use.  These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  In case of overdose, get medical help or contacta Poison Control Center right away.

Dosage & Administration



Directions •drink a full glass (8 ounces) of liquid with each dose •may be taken as a single daily dose or in divided dosesadults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hourschildren 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hourschildren 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hourschildren under 2 years of age- ask a doctordiscard unused product within 24 hours of opening bottle

Other Safety Information



Other information • magnesium content 290 mg per 1 fl oz (30 mL)•potassium content 80 mg per 1 fl oz (30mL)•store at temperatures between 46⁰ and 86⁰ F (8⁰ and 30⁰ C)

Inactive Ingredient



Inactive ingredients citric acid, lemon oil, potassium bicarbonate,sodium saccharin, water purified

Package Label.Principal Display Panel



DO NOT USE IF TAMPER EVIDENT TWIST OFF-OFF CAP IS MISSING,BROKEN OR SEPARATED FROM NECKRINGNDC37205-110-38LEADERMagnesiumCitrateOral SolutionSaline LaxativeLemon flavorPasteurizedThe Sparkling Laxative10 FL OZ (296 mL)

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