NDC | 70645-403-30 |
Set ID | 41a66fce-c4ac-4deb-9abc-26a529fd6b53 |
Category | DIETARY SUPPLEMENT |
Packager | 7T Pharma LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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DOSAGE & ADMINISTRATION
RECOMMENDED DOSAGE:
Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner. If you are pregnant or nursing, ask a healthcare professional.Genicin Vita-S contains the following inactive ingredients: Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croacarmellose Sodium, and Magnesium Stearate.
- Genicin Vita-S
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WARNINGS:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Genicin Vita-S 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.
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PRECAUTIONS:
KEEP OUT OF REACH OF CHILDREN.
Tamper Evident: Do not use if seal is broken or missing.
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.
Pregnancy and Lactation
Genicin Vita-S is not intended for use in pregnant or lactating patients.
Genicin Vita-S is supplied in:
30ct bottles (70645-403-30*)
Dispensed by Prescription† -
Dietary Supplement
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]
Protect from heat, light and moisture.
* 7T Pharma 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).1-3 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.
- Federal Register Notice of August 2, 1973 (38 FR 20750)
- Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
- Federal Register Notice of March 5, 1996 (61 FR 8760)
Genicin Vita-S Tablets
Manufactured for:
7T Pharma, LLC
Los Angeles, CA 90064
800.941.2848 - Federal Register Notice of August 2, 1973 (38 FR 20750)
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INGREDIENTS AND APPEARANCE
GENICIN VITA-S
vitamin c, thiamine, riboflavin, niacin, vitamin b6, folate, vitamin b12, biotin, panothenic acid tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:70645-403 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.5 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 10 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1000 ug METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 6 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 300 ug PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 10 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:70645-403-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 10/01/2018 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 5 mm Labeler - 7T Pharma LLC (080220022)