Provida DHA by US Pharmaceutical Corporation / Capsugel Inc Provida DHA

Provida DHA by

Drug Labeling and Warnings

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

Drug Details [pdf]

PROVIDA DHA- prenatal multivitamin and mineral supplement enhanced with dha, epa and lactobacillus casei ke-99 capsule 
US Pharmaceutical Corporation

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Provida DHA

Supplement Facts

Serving Size: 1 Capsule

Amount per Serving%DV*

% Daily Value

for Pregnant or

Lactating Women

Vitamin C (as Calcium Ascorbate)30 mg50%50%
Vitamin D3 (Cholecalciferol)400 IU100%100%
Vitamin B1 (as Thiamine Mononitrate)2 mg133%118%
Vitamin B2 (Riboflavin)3 mg176%150%
Vitamin B3 (Niacinamide)2 mg10%10%
Vitamin B6 (Pyridoxine HCL)25 mg1250%1000%
Folic acid1.25 mg313%156%
Vitamin B12 (Cyanocobalamin)10 mcg167%125%
Biotin300 mcg100%100%
Vitamin B5 (Calcium d-Pantothenate)5 mg50%50%

Iron

(16 mg from Ferrous Fumarate; 16 mg from Polysaccharide Iron Complex)

32 mg178%178%
Magnesium (as Magnesium Gluconate)7 mg1.75%1.6%
Zinc (as Zinc Gluconate)6 mg40%40%
Copper (as Cupric Sulfate)1 mg50%50%

Lactobacillus casei KE-99

200 Billion CFU/g**

30 mg

Docosahexaenoic Acid (DHA)

  Derived from 315 mg Algae Oil

110 mg

* Percent Daily Value based on 2000 calorie intake for adults and children 12 years and older.

† Daily Value not established

** Colony Forming Units per gram (CFU/g) at time of manufacturing

​Other Ingredients: FD&C Blue #1, FD&C Red #40,​ Hypromellose, Lecithin PC, Silicon Dioxide, Titanium Dioxide and Water

INDICATIONS: ProvidaTM DHA 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. ProvidaTM DHA may also be used to improve the nutritional status of women before conception.

CONTRAINDICATIONS: ProvidaTM DHA 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.
Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All ProvidaTM 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 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.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

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.

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: 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.

CAUTION: Rx only.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15⁰ to 30⁰C(59⁰ to 86⁰F). Keep in a cool, dry place.

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.

HOW SUPPLIED: ProvidaTM DHA are Swedish orange opaque capsules printed with “US” logo and “P DHA” in white. Child resistant bottles of 30 capsules NDC# 52747-503-30.

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. Manufactured with L-Vcaps® Plus capsule shells.

Manufactured in FDA registered facility in the USA.

Patent Numbers: USA: 6,797,266; 5,626,883; Mexico MX/a/2008/004461; Singapore: 20082623-9 and other countries.

Vcaps® and the L-Vcaps® Plus Logo are trademarks used under license.

ProvidaTM DHA Prenatal Multivitamin & Mineral Supplement enhanced with DHA, EPA and Lactobacillus casei KE-99

Packaging

pro1

PROVIDA DHA 
prenatal multivitamin and mineral supplement enhanced with dha, epa and lactobacillus casei ke-99 capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52747-503
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID30 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE2 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN2 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) CYANOCOBALAMIN10 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON32 mg
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLUCONATE7 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE6 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI30 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT110 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:52747-503-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement04/01/201510/01/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
shape
size (solid drugs)22 mm
scoring1
imprint
Labeler - US Pharmaceutical Corporation (048318224)

Revised: 1/2020
 
US Pharmaceutical Corporation