Provida OB

Basic Information

Product Label

Product label for Provida OB
Full Name: Provida OB
Brand: US Pharmaceutical Corporation none
Product Type: Other Combinations
Physical State: Capsule
UPC/SKU: 3 52747 50430 4
Product Version Code: Rev. 06/2013 QL-00199

Contact Information

Marketed by

Name: US Pharmaceutical Corporation
Address:P.O. Box 360465, Decatur, GA, 30036
Types: Distributor

Product Details

Net Contents

30 Capsule(s)(30 Capsule(s))

Serving Sizes

Unit:Capsule(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Biotin

vitamin
Amount: 300 mcg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 100%
Pregnant and Lactating: 100%

Group: Biotin

Also known as: Vitamin H, Vitamin B-7, Vitamin B7, d-biotin, S. cerevisiae

UNII Code: 6SO6U10H04

Copper

mineral

Notes: Copper (Form: as Copper Gluconate)

Forms:
  • as Copper Gluconate
Amount: 1 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 50%
Pregnant and Lactating: 50%

Group: Copper

Folic Acid

vitamin
Amount: 1.25 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 313%
Pregnant and Lactating: 156%

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Iron

mineral
Amount: 40 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 222%
Pregnant and Lactating: 222%

Group: Iron

Notes: Lactobacillus casei (KE-99) Genus: Lactobacillus Species: casei Note: (200 billion CFU/g) (colony forming units per gram (CFU/g) at time of manufacturing)

Amount: 30 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: % (Daily Value not established)
Pregnant and Lactating: % (Daily Value not established)

Group: Lactobacillus casei

Magnesium

mineral

Notes: Magnesium (Form: as Magnesium Oxide)

Forms:
  • as Magnesium Oxide
Amount: 20 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 5%
Pregnant and Lactating: 4%

Group: Magnesium

Vitamin B1

vitamin
Forms:
  • Thiamine Hydrochloride
Amount: 2.5 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 167%
Pregnant and Lactating: 147%

Group: Thiamin

Also known as: Thiamin, Thiamine

UNII Code: X66NSO3N35

Forms:
  • Cyanocobalamin
Amount: 12 mcg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 200%
Pregnant and Lactating: 150%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B2

vitamin
Forms:
  • Riboflavin
Amount: 3.5 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 206%
Pregnant and Lactating: 175%

Group: Vitamin B

Vitamin B3

vitamin
Forms:
  • Niacin
Amount: 10 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 50%
Pregnant and Lactating: 50%

Group: Niacin

Also known as: IP-6

UNII Code: 2679MF687A

Vitamin B5

vitamin
Forms:
  • Calcium D-Pantothenate
Amount: 6 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 60%
Pregnant and Lactating: 60%

Group: Vitamin B5

Also known as: Pantothenic Acid

UNII Code: 19F5HK2737

Vitamin B6

vitamin
Forms:
  • Pyridoxine Hydrochloride
Amount: 25 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 1250%
Pregnant and Lactating: 1000%

Group: Vitamin B6

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 60 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 100%
Pregnant and Lactating: 100%

Group: Vitamin C (unspecified)

Vitamin D3

vitamin
Forms:
  • Cholecalciferol
Amount: 400 IU
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 100%
Pregnant and Lactating: 100%

Group: Vitamin D

Also known as: Cholecalciferol, Vitashine vegan Cholecaciferol, Vitashine, Vitashine D3 Cholecalciferol, Vitashine vegan Cholecalciferol, natural Cholecalciferol, plant-based Cholecalciferol, vegan Cholecalciferol, fermented Cholecalciferol, Vitashine D3

UNII Code: 1C6V77QF41

Zinc

mineral

Notes: Zinc (Form: as Zinc Oxide)

Forms:
  • Zinc Oxide
Amount: 10 mg
Serving Size: 1 Capsule(s)
Adults and children 4 or more years of age: 67%
Pregnant and Lactating: 67%

Group: Zinc

Group: Color

Also known as: E129 FD&C Red No. 40, FD&C Red #40

Group: Color

Also known as: FD&C Blue #1

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Group: Color

Group: Color

Group: Iron

UNII Code: R5L488RY0Q

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

HPMC

other

Group: Hypromellose

Also known as: Hydroxypropylmethylcellulose, Hydroxypropyl Methyl Cellulose, Hydroxypropyl Methylcellulose, Hypromellose

Group: Hypromellose

Group: Magnesium stearate

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

Group: Cellulose

Group: Vitamin B3 (Niacin)

Also known as: Vitamin B3

UNII Code: 2679MF687A

Group: Vitamin B5 (Pantothenic Acid)

Also known as: Vitamin B5

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B2

Group: Vitamin B1 (Thiamine)

Also known as: Vitamin B1

Polysaccharide Iron Complex

non-nutrient/non-botanical

Group: Iron

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Group: Titanium Dioxide

Vitamin H

vitamin

Group: Vitamin B7 (biotin)

Also known as: Biotin

UNII Code: 6SO6U10H04

Product Statements

General Statements: All Other Content

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.

Precautions re: All Other

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.

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