The following Structured Product Label (SPL) was submitted to the FDA by Avpak for the product Prenatal Plus (NDC 50268-677). 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, indications and usage, warnings, precautions, dosage and administration, how supplied, storage, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Prenatal Plus Vitamin and Mineral Tablet is an orally administered prenatal / postnatal prescription dietary supplement for both lactating and non-lactating mothers and should be administered under the supervision of a licensed medical practitioner.
To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.
| WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. |
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.
Call your licensed medical practitioner about side effects.
To report a serious adverse event or obtain product information, contact AvKARE at 1-855-361-3993; email [email protected]
Before, during and/or after pregnancy, one tablet daily with a meal, or as directed by a licensed medical practitioner.
Prenatal Plus Vitamin and Mineral Tablets are beige colored tablets, debossed with "677" on one side, dispensed in bottles of 100 tablets (NDC 50268-677-01)
STORE AT CONTROLLED ROOM TEMPERATURE 15° to 30°C (59° to 86°F).
Protect from light and moisture. Dispense in a tight, light-resistant container with child-resistant closure.
Manufactured for:
AvKARE
Pulaski, TN 38478
Rev. 11/2021
AV Rev. 11/2021
100 (677 01)
* Please review the disclaimer below.
