FDA Label for Prenatal Plus
View Indications, Usage & Precautions
Prenatal Plus Product Label
The following document was submitted to the FDA by the labeler of this product Avpak. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
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.
Indications And Usage
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.
Warnings
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. |
Precautions
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]
Dosage And Administration
Before, during and/or after pregnancy, one tablet daily with a meal, or as directed by a licensed medical practitioner.
How Supplied
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)
Storage
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
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