Active Ingredient (30Ml (Approx. 1 Fl. Oz))
Magnesium citrate 1.745g
Magnesium Citrate
FDA Label NDC 71399-7889
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc for the product Magnesium Citrate (NDC 71399-7889). 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 (30ml (approx. 1 fl. oz)), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, when using this product, 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
Purpose
Saline laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 1/2 to 6 hours
Do Not Use
laxative products for longer than 1 week unless directed by a doctor.
Ask A Doctor Before Use If You Have
- kidney disease
- a magnesium restricted diet
- a sodium restricted diet
- stomach pain, nausea or vomiting
- noticed a sudden change in bowel habits that lasts more than 1 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 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 (1-800-222-1222) right away.
Directions
- 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 | 1/2 bottle to 1 bottle (10 fl oz) |
| children 6 to 11 years of age | 1/3 bottle to 1/2 bottle |
| children under 6 years of age | consult a doctor |
Other Information
- each fliud ounce contains: magnesium 280 mg, sodium 6.7 mg
- store between 46°-86°F (8°-30°C). Do not refrigerate.
- protect from excessive heat and freezing
- discard unused product within 24 hours of opening bottle
Inactive Ingredients
Purified water, citric acid, lemon flavor, sodium benzoate, saccharin sodium, sorbic acid, disodium edetate
Questions Or Comments?
Call toll-free 1-877-225-6999
Manufactured for:
Akron Pharma Inc.,
Fairfield, NJ-07004
www.akronpharma.com
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