Label: RESTORA RX (folic acid, lactobacillus casei- ke-99 capsule
- NHRIC Code(s): 52747-207-30
- Packager: U.S. Pharmaceutical Corporation
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated June 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
STATEMENT OF IDENTITY
Supplement Facts
Serving Size: 1 Capsule Servings Per Carton: 30
Amount Per Serving
% DV*% Daily Value for
Pregnant orLactating Women
Folic Acid
Lactobacillus casei (KE-99),
200 Billion CFU/g **1.25 mg
60 mg
313%
†208%
†
* % Daily Values are based on a 2,000 calorie intake of adults and children 12 years and older. † Daily Value not established
**Colony Forming Units (CFU) per gram at time of manufacturingOther Ingredients: FD&C Blue #1, Flaxseed Oil Powder, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose and Titanium Dioxide.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. -
DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12. You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036.
-
PRECAUTIONS
PRECAUTIONS: As with other nutritional supplements, consult a physician if you are taking medications, diabetic, are pregnant or nursing; keep out of the reach of children and pets.
Folic Acid: Folic Acid is one of the important hematopoietic agents necessary for proper regeneration of the blood-forming elements and their function. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.
-
WARNINGS
WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
PRECAUTIONS: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure the signs and symptoms of pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive. The use of this product by immunocompromised patients or treatment of any disorder must be medically supervised by a physician.
HOW SUPPLIED: Restora RxTM are light blue opaque Vcaps® capsules printed in white with “R207” on the cap and “US” Logo on the body. Packed in child resistant cap and light resistant bottle of 30 capsules (52747-0207-30). The listed product number is not a National Drug Code. Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
- SAFE HANDLING WARNING
- HEALTH CLAIM
- Packaging
-
INGREDIENTS AND APPEARANCE
RESTORA RX
folic acid, lactobacillus casei (ke-99) capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:52747-207 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.25 mg LACTICASEIBACILLUS CASEI (UNII: SA940P2U00) (LACTICASEIBACILLUS CASEI - UNII:SA940P2U00) LACTICASEIBACILLUS CASEI 60 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LINSEED OIL (UNII: 84XB4DV00W) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:52747-207-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 12/01/2014 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 22 mm scoring 1 imprint Labeler - U.S. Pharmaceutical Corporation (079467662)
