Tamper Evident Statement
Do not use if tamper evident twist-off cap is missing, broken or separated from neckring.
Magnesium Citrate Liquid
FDA Label NDC 87438-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pinnacle Rx Llc � for the product Magnesium Citrate (NDC 87438-0002). 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 tamper evident statement, active ingredient (in each fl oz), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Fl Oz)
Magnesium citrate 1.745 g
Purpose
Saline laxative
Uses
- for relief of occasional constipation (irregularity).
- Generally produces bowel movement in ½ to 6 hours
Warnings
for this product.
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 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.
Storage
Store at temperatures between 46° and 86° F (8° and 30° C).
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
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
Claims
Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives
Adverse Reaction
Distributed By: Pinnacle Rx LLC
368 New Hempstead Rd Suite 6-65
New City, NY 10956
Principal Display Panel
MedRite
Magnesium Citrate
Saline Laxative
Low Sodium
Lemon Flavor
MADE IN THE USA WITH US AND FOREIGN COMPONENTS
10 FL OZ (296 mL)
Mm01 (Mm01)
* Please review the disclaimer below.
