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Neonatal Complete

Generic Name: prenatal vitamins
Dosage Form: tablet

Medically reviewed by Drugs.com. Last updated on Sep 1, 2020.

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.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Neonatal Complete Description

Each tablet contains:

VITAMIN A (AS 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 CUPRIX 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, croscarmellose sodium, silicon dioxide, magnesium stearate, HPMC E15, HPMC E5/E6,titanium dioxide,PEG-8000, Talc.

INDICATIONS

NEONATAL 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.

Warning

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 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.

Neonatal Complete Dosage and Administration

One tablet and one capsule daily or as directed by a physician.

STORAGE

Store at 15°C to 30°C (69°F to 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 of tablet.

HOW SUPPLIED

100 Prenatal Vitamin Tablets - NDC 73317-8286-1.

To report a serious adverse event or obtain product information, call 1-866-760-6565.

Please consult your health care provider with any dietary concerns.

Call your licensed medical practitioner about side effect.

Manufactured for and Distributed by:

AUM Pharmaceuticals
Hauppauge, NY 11788.

Made in USA

NEONATAL COMPLETE
vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:73317-8286
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (.BETA.-CAROTENE) BETA CAROTENE 1200 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 25 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 18.4 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 3 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1000 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 8 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 29 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 15 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 3 mg
BIOTIN (BIOTIN) BIOTIN 30 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 7 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 100 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 8000
TALC
Product Characteristics
Color white Score no score
Shape CAPSULE Size 6mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:73317-8286-1 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/15/2020
Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
Registrant - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
Establishment
Name Address ID/FEI Operations
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS 081225162 manufacture(73317-8286)
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS