Drug Facts Active Ingredient (In Each Fl Oz)
Magnesium citrate 1.745 g
Magnesium Citrate Solution
FDA Label NDC 85786-503
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Magnesium Citrate (NDC 85786-503). 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 drug facts 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, if pregnant 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 laxative
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 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 And Handling
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
Questions Or Comments?
(855)-280-1079
Principal Display Panel
NDC 85786-503-10
DR. SIMI
Magnesium Citrate
Saline Laxative
Oral Solution
■ Sugar Free
■ For relief of occasional constipation
Lemon Flavor
Alcohol Content 0.025% (from flavoring)
10 fl oz (296 mL)
DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN, OR SEPARATED FROM NECKRING
Distributed by:
FARMACIAS DE SIMILARES TX LLC.
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
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