PRENATVITE COMPLETE tablet

PRENATVITE COMPLETE by

Drug Labeling and Warnings

PRENATVITE COMPLETE by is a Other medication manufactured, distributed, or labeled by SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

SUPPLEMENT FACTS:

Serving Size: One Tablet

RX PRENATAL VITAMIN with 1,000 IU Vitamin D Complete Vitamin for before, during and after pregnancy.

Each PRENATVITE PLUS tablet contains:
VITAMIN A (AS ACETATE, BETA CAROTENE)		1200 MCG
VITAMIN C (ASCORBIC ACID)		120 MG
VITAMIN D3 (AS CHOLECALCIFEROL)		25 MCG
VITAMIN E (AS DL-ALPHA TOCOPHEROL ACETATE)		18.4 MG
VITAMIN B1 (AS THIAMINE MONONITRATE)		3 MG
VITAMIN B2 (AS RIBOFLAVIN)		3 MG
VITAMIN B3 (AS NIACINAMIDE)		20 MG
VITAMIN B6 (AS PYRIDOXINE HCL)		3 MG
FOLIC ACID		1000 MCG
VITAMIN B12 (AS CYANOCOBALAMIN)		8 MCG
CALCIUM (AS CALCIUM CARBONATE)		200 MG
IRON (AS FERROUS FUMARATE)		29 MG
ZINC (AS ZINC OXIDE)		15 MG
COPPER (AS CUPRIC OXIDE)		3 MG
BIOTIN		30 MCG
PANTOTHENIC ACID (AS CALCIUM-D- PANTOTHENATE		7 MG
MAGNESIUM (AS MAGNESIUM OXIDE)		100 MG
IODINE (AS POTASSIUM IODIDE )		150 MCG

Other Ingredients:

microcrystalline cellulose, stearic acid, magnesium stearate, croscarmellose sodium, silicon dioxide, PEG-8000, talc, Titanium dioxide, HPMC E15, HPMC E5/E6

INDICATIONS
PRENATVITE COMPLETE is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS

WARNINGS

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.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient.
PRECAUTIONS
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid
DOSAGE AND ADMINISTRATION

One tablet daily or Take exactly as prescribed by your doctor. Take

PRENATVITE COMPLETE tablet each day at any time of day at about the same time each day.

PRENATVITE COMPLETE can be taken with or without food.

STORAGE
Store at 20-25°C (68-77°F) [See USP controlled room temperature].

Do not keep medicine that is out of date or that you no longer need.

Keep PRENATVITE COMPLETE Tablets and all medicines out of the reach of children.

NOTICE
Contact with moisture can discolor or erode the tablet.

HEALTH CLAIM

HOW SUPPLIED

Bottles of 90 tablets each - NDC: 73317-2220-9

To report a serious adverse event or obtain product information, call 631-524-5758

Call your licensed medical practitioner about side effect.

You may report side effects by calling AUM 1-631-524-5758.

Manufactured and Distributed by:

AUM Pharmaceuticals
Hauppauge, NY 11788.

Made in USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRENATVITE COMPLETE 
prenatvite complete tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:73317-2220
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1200 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	25 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	18.4 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	3 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	8 ug
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	29 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	200 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	3 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	30 ug
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	7 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	100 mg
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	150 ug

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:73317-2220-9	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		02/03/2020

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
size (solid drugs)	6 mm
shape

Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)

Establishment
Name	Address	ID/FEI	Business Operations
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS		081225162	repack(73317-2220)