Active Ingredient
Magnesium citrate 1.745g per fl oz
Magnesium Citrate
FDA Label NDC 83059-0127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Magnesium Citrate (NDC 83059-0127). 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, use, 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
Purpose
Saline Laxtive
Use
- for relief of occasional constipation (irregularity).
- Generally produces bowel movement in 1/2 to 6 hours
Warnings
Otc - Ask Doctor
Ask a doctor before use if you have
- kidney disease
- a magnesium restricted diet
- abdorominal 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 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.
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 (1-800-222-1222).
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 3 to 12 years of age | 7 fl oz maximum 7 fl oz in 24 hours |
| children 2 to under 6 years of age | 2 to 3 fl oz in 24 hours maximum 3 fl oz in 24 hours |
| children under 2 years of age | ask a doctor |
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
Inactive Ingredients
benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water
Questions?
1-800-373-6981
* Please review the disclaimer below.
