Label: PROVIDA OB- prenatal multivitamin mineral supplement enhanced with lactobacillus casei ke-99 capsule

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated September 30, 2014

If you are a consumer or patient please visit this version.

  • 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 mg100%100%
     Vitamin D3 (Cholecalciferol) 400 IU100%100%
    Vitamin B1 (Thiamine Hydrochloride)2.5 mg167%147%
    Vitamin B2 (Riboflavin)3.5 mg206%175%
    Vitamin B3 (Niacin)10 mg50%50%
    Vitamin B6 (Pyridoxine HCI)25 mg1250%1000%
    Folic Acid1.25 mg313%156%
    Vitamin B12 (Cyanocobalamin)12 mcg200%150%
    Biotin300 mcg100%100%
    Vitamin B5 (Calcium d-Pantothenate)6 mg60%60%

    Iron

    (20 mg from Ferrous Fumarate; 20 mg from Polysaccharide Iron Complex)

    40 mg222%222%
    Magnesium (as Magnesium Oxide)20 mg5%4%
    Zinc (as Zinc Oxide)10 mg67%67%
    Copper (as Copper Gluconate)1 mg50%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.

  • WARNINGS

    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

    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

    Store at controlled room temperature 15°C to 30°C (59° to 86° F). Keep in cool, dry place.

  • 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

    Prenatal Multivitamin & Mineral Supplement enhanced with Lactobacillus casei KE-99

  • Packaging

    Provida -OB

  • INGREDIENTS AND APPEARANCE
    PROVIDA OB 
    prenatal multivitamin mineral supplement enhanced with lactobacillus casei ke-99 capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52747-504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE2.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.5 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN10 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.25 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.012 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.3 mg
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID6 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON40 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE20 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
    COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
    LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI30 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:52747-504-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement06/01/2013
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)19 mm
    scoring1
    imprint
    Labeler - US Pharmaceutical Corporation (048318224)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABS Corporation048022727manufacture(52747-504)