Otc - Active Ingredient
Active ingredientMagnesium citrate 1.745 g per fl oz
Citrate Of Magnesium
FDA Label NDC 54868-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Citrate Of Magnesium (NDC 54868-0010). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 you use if you have• kidney disease• a magnesium or potassium-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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your are taking any other drug.Take this product 2 or more 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 bowel movement 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 contact a Poison Control Center right away.
Dosage & Administration
Directions • drink a full glass (8 ounces) of liquid wit 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 - 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 (30 mL)• store at temperatures between 46⁰ and 86⁰F (8⁰ and 30⁰ C)
Inactive Ingredient
Inactive ingredients citric acid, lemon oil, potassium bicarbonate,sodium saccharin, water purified
Adverse Reactions
Distributed by:Vi-JonOne Swan DriveSmyrna, TN 37167
Other
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
Package Label.Principal Display Panel
NDC 54868-0010-0Very Low SodiumCitromaMAGNESIUM CITRATELemony•Saline Laxative•Oral SolutionDo not use if tamper evident twist-off capis missing, broken or separated from neck ring10FL OZ (296 mL)
* Please review the disclaimer below.
