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Health Claim

FOLIKA-NC
Dietary Supplement
Dispensed by Prescription

HOW SUPPLIED HEALTH CLAIM:

FOLIKA-NC Tablets are supplied as a small, round, yellow, clear-coated tablet, with debossed “A” on one side.

Manufactured for: Innovida Pharmaceutique Corporation

Call your doctor for medical advice about side effects. You may report side effects to Innovida Pharmaceutique at 1-888-919-0980

*Innovida Pharmaceutique Corp. does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

† This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

Storage and Handling

Store at 20° to 25°C (68° to 77°F; excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]

Dosage and Administration

Usual adult dose is 1 tablet by mouth once or twice daily or as prescribed by a licensed medical practitioner.

Warnings

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

PRECAUTIONS

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

FOLIKA-NC Tablets should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress.

Keep out of reach of children. Pregnancy and Lactation:

FOLIKA-NC Tablets is not intended for use in pregnant or lactating patients

ADVERSE REACTIONS

Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.