NDC 52747-504-30
Rx only
Consult package literature for full prescription information.
FDA Statement of Identity
Prenatal multivitamin & mineral supplement enhanced with Lactobacillus casei KE-99
Formula re: Contains
Prenatal multivitamin & mineral supplement enhanced with Lactobacillus casei KE-99
Precautions re: All Other
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.
Formulation re: Other
Manufactured with Vcaps Plus capsule shells.
Storage
Store at controlled room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F). Keep in a cool, dry place.
Formulation re: Other
Manufactured in a FDA registered facility in the USA.
Precautions re: All Other
Caution: Rx only.
Brand IP Statement(s) re: (c), (TM), (SM)
Patent Numbers: USA: 6,797,266; 5,626,883; Mexico MX/a/2008/004461; Singapore: 200802623-9 and other countries.
Precautions re: Children
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.
Formula re: Type
Indications: Provida OB is a prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Provida OB may also be used to improve the nutritional status of women before conception.
Contraindications: Provida OB 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 hemolytic anemias. It is also contraindicated in patients suffering from pernicious anemia as folic acid may obscure its signs and symptoms.
Brand IP Statement(s) re: (c), (TM), (SM)
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).
Formula re: Contains
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 o 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".
General Statements: All Other Content
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).
Formula re: Contains
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.
Precautions re: All Other
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.
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.
Precautions re: Children
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.
Suggested/Recommended/Usage/Directions
Dosage and Administration: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician.
Precautions re: All Other
Do not exceed recommended dosage.
Precautions re: Children
Do not administer to children under the age of 12.
General Statements: All Other Content
How Supplied: Provida OB are Swedish Orange Opaque Vcaps capsules printed with "US" logo and "ProV". Child resistant bottles of 30 capsules, NDC# 52747-504-30. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.
Storage
Store at controlled room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F). Keep in a cool, dry place.
Precautions re: All Other
Caution: Rx only.
Brand IP Statement(s) re: (c), (TM), (SM)
Vcaps and the Vcaps Logo are trademarks used under license.
US Pharmaceutical Corporation Provida OB | Supplement DB