Magnesium Citrate
FDA Label NDC 21695-934

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Magnesium Citrate (NDC 21695-934). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Magnesium Citrate 1.745g per fl oz

Purpose

saline laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 1/2 to 6 hours

Warnings

ask a doctor before use if you have:

kidney disease

a magnesium restricted diet

stomach pain,  nausea or vomiting

noticed a sudden change in bowel habits that lasts more than one week

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug

When Using This Product

do not exceed the maximum recommended daily dosage in a 24 hour period

Stop Use And Ask A Doctor If

you have rectal bleeding or no bowel movement after use .

These could be a sign of a serious condition.

you need to use a laxative more than one week.

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep This And All Drugs Out Of The Reach Of Children.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

Adults and Children 12 years of age and older             1/2 to 1 bottle (10 fl oz). Drink a full 8 oz glass of liquid with each dose.                                                                                 The dose may be taken as a single daily dose or in divided doses.

children 6 to under 12 years of age                               1/3 to 1/2 bottle with a full 8 oz glass of liquid.

children under 6 years of age                                        consult a doctor


Other Information

store at controlled room temperature

protect from excessive heat and freezing

discard unused product within 24 hours of opening bottle


Inactive Ingredients

Citric acid, flavors, potassium bicarbonate, saccharin sodium, purified water

Questions Or Comments?

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