The following Structured Product Label (SPL) was submitted to the FDA by Neomed Pharmaceutical for the product Neonatal Plus Vitamin (NDC 70898-115). 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 boxed warning, statement of identity, indications & usage, contraindications, precautions, adverse reactions, dosage and administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Each prenatal tablet contains:
Each Tablet contains: | ||
Vitamin A (as acetate, beta carotene) | 1200 mcg | |
Vitamin D3 (as cholecalciferol) | 10 mcg | |
Vitamin E (as dl-alpha topcopheryl acetate ) | 9.2 mg | |
Vitamin C (Ascorbic acid ) | 20 mg | |
Vitamin B1 (as thiamine HCl) | 1.84 mg | |
Vitamin B2 (as riboflavin) | 3 mg | |
Vitamin B3 (as niacinamide) | 20 mg | |
Vitamin B6 (as pyridoxine HCl) | 10 mg | |
Folic acid | 1000 mcg | |
Vitamin B12 (as cyanocobalamin) | 12 mcg | |
Iron (as ferrous fumarate ) | 27 mg | |
Citrus bioflavonoids complex 50% bio flavonoids | 2 mg | |
Calcium (as carbonate sulfate ) | 200 mg | |
Zinc (as zinc oxide ) | 25 mg | |
Copper (as cupric oxide) | 2 mg | |
Boron (as boron citrate ) | 0.2 mg | |
Inositol | 5 mg | |
Other Ingredients: , microcrystalline croscarmellose sodium, stearic acid, silicon dioxide, titanium dioxide (as color), polyethylene glycol, sucrose, magnesium stearate, talc,triacetin, HPMC E15,HPMC E5/E6,FD&C RED #40 (LAKES),FD&C YELLOW # 6 (LAKE )
NEONATAL PLUS TABLET Rx 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.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
To report a serious adverse event or obtain product information, call 631-524-5758
One tablet daily or as directed by a physician.
Bottles of 100 tablets each - NDC 70898-115-01
Store at 20-25°C (68-77°F) [See USP controlled room temperature].
To report a serious adverse event or obtain product information, call 631-524-5758
Distributed by:
Neomed Pharmaceutical ,80 Cain Dr, Brentwood,NY 11717
Phone :631-524-5758
Email: [email protected]
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