Description
M-Natal Plus Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner.
M-natal Plus Tablet
FDA Label NDC 58657-170
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product M-natal Plus (NDC 58657-170). 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 description, dosage and administration, warning:, caution, how supplied, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage And Administration
Before, during and/or after pregnancy, one tablet daily, with a meal, or as directed by a licensed healthcare practitioner regardless of lactation status.
Warning:
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Caution
High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.
Store at 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.
Call your licensed medical practitioner about side effects. You may report side effects by calling Method at 1-877-250-3427 or FDA at 1-800-FDA-1088.
How Supplied
Supplied as beige tablet, imprinted "M170" dispensed in bottles of 100 tablets.
Manufactured By:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118
Rev. 08/2018
Principal Display Panel
NDC 58657-170-01
M-Natal Plus
tablet
PRENATAL/POSTNATAL
100 Tablets
Rx Only
Principal Display Panelndc 58657-170-01m-natal Plus Tabletprenatal/postnatal100 Tabletsrx Only (M Natal Plus 01)
Principal Display Panelndc 58657-170-01m-natal Plus Tabletprenatal/postnatal100 Tabletsrx Only (M Natal Plus 02)
* Please review the disclaimer below.
