Label: PROVIDA OB- prenatal multivitamin mineral supplement enhanced with lactobacillus casei ke-99 capsule
- NHRIC Code(s): 52747-504-30
- Packager: US Pharmaceutical Corporation
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated September 30, 2014
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STATEMENT OF IDENTITY
Supplement Facts Serving Size: 1 Tablet Amount per Serving % DV* % Daily value for Pregnant or lactating woman Vitamin C (Ascorbic Acid) 60 mg 100% 100% Vitamin D3 (Cholecalciferol) 400 IU 100% 100% Vitamin B1 (Thiamine Hydrochloride) 2.5 mg 167% 147% Vitamin B2 (Riboflavin) 3.5 mg 206% 175% Vitamin B3 (Niacin) 10 mg 50% 50% Vitamin B6 (Pyridoxine HCI) 25 mg 1250% 1000% Folic Acid 1.25 mg 313% 156% Vitamin B12 (Cyanocobalamin) 12 mcg 200% 150% Biotin 300 mcg 100% 100% Vitamin B5 (Calcium d-Pantothenate) 6 mg 60% 60%
(20 mg from Ferrous Fumarate; 20 mg from Polysaccharide Iron Complex)
40 mg 222% 222% Magnesium (as Magnesium Oxide) 20 mg 5% 4% Zinc (as Zinc Oxide) 10 mg 67% 67% Copper (as Copper Gluconate) 1 mg 50% 50% Lactobacillus casei KE-99
200 Billion CFU/g**
30 mg † † *Percent Daily Value based on 2000 calorie intake for adults and children 12 years and older.
† Daily value not established
** Colony-forming units (CFU) per gram at time of manufacturing
STATEMENT OF IDENTITY
INDICATIONS : Provida OBTM is a prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal periods to lactating and non-lactating mothers. Provida OBTM may also be used to improve nutritional status of women before conception. CONTRADICTIONS: Provida OBTM is contraindicated in patients with a known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or haemolytic anemias. It is also contraindicated in patients suffering from pernicious anemia as folic acid may obscure its signs and symptoms.
Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All Provida products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No. 11/243,043 Pending). “An increase in tolerability is observed with the formulation and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient’s blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism”.
Clinical Studies: Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias: PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No.3. pp.213-220 (July-September 1982).
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 jejuna 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.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
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 haematological 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.
Consult package literature for full prescription information. 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. Marketed by US Pharmaceutical Corporation
CAUTION: Rx only.
Patent Numbers: USA: 6,797,266; 5,626,883; Mexico MX/a/2008/004461; Singapore: 200802623-9 and other countries.
- SAFE HANDLING WARNING
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.
OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted.
- HEALTH CLAIM
INGREDIENTS AND APPEARANCE
prenatal multivitamin mineral supplement enhanced with lactobacillus casei ke-99 capsule
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:52747-504 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 2.5 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.5 mg NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 10 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.25 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 0.012 mg BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 0.3 mg CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 6 mg IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 40 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 20 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10 mg COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI 30 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:52747-504-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 06/01/2013 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 19 mm scoring 1 imprint Labeler - US Pharmaceutical Corporation (048318224) Establishment Name Address ID/FEI Business Operations ABS Corporation 048022727 manufacture(52747-504)