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. 09/2022

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

Children 4 or More Years of AgePregnant WomenAdult Female (18 - 50 Years)Lactating

Servings Per Container

30

Ingredients & Nutrition

Biotin

vitamin

Group: Biotin

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

UNII Code: 6SO6U10H04

Group: Color

Also known as: FD&C Blue #1

COPPER

mineral

Group: Copper

Group: Color

UNII Code: H3R47K3TBD

Group: Iron

UNII Code: R5L488RY0Q

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

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

UNII Code: 935E97BOY8

HPMC

other

Group: Hypromellose

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

Group: Lactobacillus casei

Group: Cellulose

Microcrystalline cellulose (MCC) is a refined wood pulp that is commonly used as a texturizer, anti-caking agent, and bulking agent in food and dietary supplements. It is a white, odorless powder that is insoluble in water and is often used to improve the texture and stability of products.

Also known as: Cellulose, MCC

Group: Vitamin B3 (Niacin)

Also known as: Vitamin B3

UNII Code: 2679MF687A

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B2

Group: Vitamin B1 (Thiamine)

Also known as: Vitamin B1

Group: Vitamin B5 (Pantothenic Acid)

Also known as: Vitamin B5, Vitamin B-5, B5, B-5

UNII Code: 19F5HK2737

Polysaccharide Iron Complex

non-nutrient/non-botanical

Group: Iron

Group: Vitamin B6 (pyridoxine)

Pyridoxine, commonly known as Vitamin B6, is a water-soluble vitamin that plays a critical role in brain health, production of neurotransmitters, and the metabolism of proteins, fats, and carbohydrates. It is essential for the proper functioning of sugars, fats, and proteins in the body and is crucial for the development of the brain and nervous system.

Also known as: Vitamin B6

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Group: Color

Red 40, also known as Allura Red AC, is a synthetic azo dye derived from petroleum used extensively as a red food colorant. It is approved by the FDA for use in foods, beverages, cosmetics, and pharmaceuticals. It imparts a bright red hue and is commonly found in candies, soft drinks, baked goods, and other processed products.

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

UNII Code: 2Z6R9D8D4B

Vitamin B1

vitamin

Group: Thiamin

Also known as: Thiamin, Thiamine

UNII Code: X66NSO3N35

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin b2

vitamin

Group: Vitamin B

Vitamin B3

vitamin

Group: Niacin

Also known as: IP-6

UNII Code: 2679MF687A

Vitamin B5

vitamin

Group: Vitamin B5 (unspecified)

Vitamin B5, also known as Pantothenic Acid, is an essential nutrient that plays a key role in the synthesis and metabolism of carbohydrates, proteins, and fats. It is a water-soluble vitamin which means it needs to be consumed regularly as it is not stored in the body. Vitamin B5 is involved in the production of coenzyme A, which is vital for many biochemical reactions.

Also known as: Pantothenic Acid

VITAMIN B6

vitamin

Vitamin D3

vitamin

Group: Vitamin D

Vitamin D3, also known as cholecalciferol, is a fat-soluble vitamin that plays a crucial role in bone health by aiding in the absorption of calcium and phosphorus in the body. It can be produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Additionally, Vitamin D3 is found in dietary supplements and fortified foods to help maintain adequate levels for optimal health.

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Group: Vitamin B7 (biotin)

Vitamin H, commonly known as Biotin or Vitamin B7, is a water-soluble vitamin that is part of the vitamin B complex. It's essential for energy production and the metabolism of carbohydrates, fats, and proteins. Biotin also plays a vital role in maintaining healthy skin, hair, and nails.

Also known as: Biotin

UNII Code: 6SO6U10H04

Product Statements

General Statements: All Other Content

Rx only

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

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 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.

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 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".

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.

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. Do not exceed recommended dosage. Do not administer to children under the age of 12.

Precautions re: Children

Do not administer to children under the age of 12.

General Statements: All Other Content

The listed product number is not a National Drug Code. Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

Precautions re: All Other

Caution: Rx only.

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

General Statements: All Other Content

Consult package literature for full prescription information. Manufactured with Vcaps Plus capsule shells.

Storage

Store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F) and dry place.

Formulation re: Other

Manufactured in a FDA registered facility in the USA.

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. Vcaps and the Vcaps Logo are trademarks used under license.

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.

General Statements: All Other Content

Lift here for full prescription information

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

HOW supplied: Provida OB™ are swedish orange opaque Vcaps® capsules printed in white "US" Logo on the cap and “ProV” on the body.

Precautions re: Children

Packed in child resistant cap and light resistant bottle of 30 capsules (52747-0504-30).

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