LORID- folic acid,thiamine, vitamin c, riboflavin, niacin, vitamin b6, vitamin b12,biotin,pantothenic acid tablet 
TMIG Inc.

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HEALTH CLAIM:

Lorid Tablets Dietary Supplement

Dispensed by Prescription

Suppliment Facts
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

DESCRIPTION:

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

Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner. Do not exceed daily recomended dosage without consulting your physician

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.

  1. Federal Register Notice of August 2, 1973 (38 FR 20750)
  2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
  3. Federal Register Notice of March 5, 1996 (61 FR 8760)

STORAGE AND HANDLING:

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.

KEEP OUT OF THE REACH OF CHILDREN.

Tamper Evident: Do not use if seal is broken or missing.

image description

LORID 
folic acid,thiamine, vitamin c, riboflavin, niacin, vitamin b6, vitamin b12,biotin,pantothenic acid tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69176-650
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID200 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN.03 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN.3 mg
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE8 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69176-650-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement08/08/2018
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
shape
imprint
size (solid drugs)18 mm
scoring1
Labeler - TMIG Inc. (036572986)

Revised: 9/2018
Document Id: 51250a35-0409-4a4d-968f-5b375b24c82e
Set id: 06514905-3948-4006-ba2c-ed23e92135c7
Version: 2
Effective Time: 20180911
 
TMIG Inc.