PRENATAL PLUS- vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mon

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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SPC SPC (SPC)
12-04-2022

active_ingredient:

.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T), BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR

MAH:

AvPAK

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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.

leaflet_short:

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 15º to 30ºC (59º to 86ºF). 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

authorization_status:

unapproved drug other

SPC

                                PRENATAL PLUS- VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID,
CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE
MONONITRATE,
RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID,
CYANOCOBALAMIN,
CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET,
FILM
COATED
AVPAK
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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PRENATAL PLUS VITAMIN AND MINERAL TABLET
MULTI-VITAMIN PRENATAL / POSTNATAL
DIETARY SUPPLEMENT
RX ONLY
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 drugsafety@avkare.com
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-
                                
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