Label: LORID- folic acid,thiamine, vitamin c, riboflavin, niacin, vitamin b6, vitamin b12,biotin,pantothenic acid tablet
- NHRIC Code(s): 69176-650-30
- Packager: TMIG Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated September 11, 2018
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Lorid Tablets Dietary Supplement
Dispensed by Prescription†
Serving Size: 1 tablet
Servings per container: 30
Amount per serving: % Daily Value
Vitamin C ( as ascorbic acid) 200 mg 335%
Folic Acid 1mg 250%
Thiamine (as thiamine cononitrate) 1.5 mg 100%
Riboflavin 1.7 mg 100%
Niacin (as niacinamide) 20 mg 100%
Biotin 300 mcg 100%
Pantothenic Acid (as d-calcium pantothenate) 1mg 250%
Vitamin B6 (as pyridoxne HCL) 8 mg 400%
Vitamin B12 (as methylcobalamin) 30 mcg 500%
OTHER INGREDIENTS: microcrystalline cellulose, croscarmellose sodium, pharmacutical glaze, mono and diglycerides, starch, calcium stearate,silicon dioxide
Lorid Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.
WARNING AND PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Lorid 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.
Pregnancy and Lactation
Lorid is not intended for use in pregnant or lactating patients.
- DOSAGE & ADMINISTRATION
HOW SUPPLIED HEALTH CLAIM:
Lorida tablets are supplied as tan, oblong shaped tablets in a child-resistant bottle of 30ct. (69176-0650-30*)
Dispensed by Prescription†
*TMIG Inc. 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)
- STORAGE AND HANDLING:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
folic acid,thiamine, vitamin c, riboflavin, niacin, vitamin b6, vitamin b12,biotin,pantothenic acid tablet
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69176-650 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 200 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN .03 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN .3 mg PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 1 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 8 mg THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.5 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) CALCIUM STEARATE (UNII: 776XM7047L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69176-650-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 08/08/2018 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape imprint size (solid drugs) 18 mm scoring 1 Labeler - TMIG Inc. (036572986)