Active Ingredient
Magnesium citrate 1.745g per fl oz
Magnesium Citrate Liquid
FDA Label NDC 69452-398
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma, Inc. for the product Magnesium Citrate (NDC 69452-398). 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, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Saline Laxtive
Uses
■ For relief of occasional constipation (irregularity).
■ Generally produces bowel movement in ½ to 6 hours
Warnings
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.
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 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.
Other Information
Store at temperatures between 46° and 86°F (8° and 30° C)
■ each fl oz contains: magnesium 290 mg
■ each fl oz contains: sodium 1 mg
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 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 |
Inactive Ingredients
benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water
Questions?
1-888-235-2466
Other
Do not use if tamper evident twist-off cap is missing, broken, or separated from neckring
Distributed by:
Bionpharma Inc., Princeton, NJ 08540
L0001053
R0525
10 Fl Oz Bottle Label
• dye-free • sugar-free
a+ health TM
magnesium
citrate
saline laxative / oral solution
alcohol content 0.025%
(from flavoring)
lemon
flavor
10 fl oz (296 mL)
Bottle (Bottle)
* Please review the disclaimer below.
