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

Provida OB by

Drug Labeling and Warnings

Provida OB by is a Other medication manufactured, distributed, or labeled by US Pharmaceutical Corporation, ABS Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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%
Iron (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.

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

INGREDIENTS AND APPEARANCE

PROVIDA OB 
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)