Concept-OB

Basic Information

Product Label

Product label for Concept-OB
Full Name: Concept-OB
Brand: US Pharmaceutical Corporation none
Product Type: Other Combinations
Physical State: Capsule
UPC/SKU: 3 52747 62030 1
Product Version Code: Rev. 03/2022

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

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Group: Vitamin C

Also known as: Vitamin C, Vit. C

UNII Code: PQ6CK8PD0R

Group: Vitamin C

Also known as: Vitamin C

UNII Code: QN83US2B0N

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

Group: Calcium Ascorbate

Also known as: Ca Ascorbate

UNII Code: 183E4W213W

Citrus Bioflavonoids

non-nutrient/non-botanical

Group: Flavonoid (mixture)

UNII Code: BD70459I50

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

Glutathione

non-nutrient/non-botanical

Group: Glutathione

Also known as: Setria

UNII Code: GAN16C9B8O

Hesperidin

non-nutrient/non-botanical

Group: Hesperidin

Hesperidin is a citrus bioflavonoid predominantly found in the peel and membranes of citrus fruits. It is known for its antioxidant, anti-inflammatory, and vascular-supporting properties.

UNII Code: E750O06Y6O

HPMC

other

Group: Hypromellose

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

L-Cysteine

amino acid

Group: Cysteine

UNII Code: K848JZ4886

Group: Magnesium ascorbate

Also known as: Mg Ascorbate

UNII Code: 0N1G678593

Group: Niacinamide ascorbate

UNII Code: JTL8B7TVW7

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: Potassium ascorbate

Also known as: K Ascorbate

UNII Code: X5523762RI

Group: Proprietary Blend (Combination)

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

Sodium Ascorbate

non-nutrient/non-botanical

Group: Sodium Ascorbate

Also known as: Na Ascorbate

UNII Code: S033EH8359

Group: Vitamin C (ascorbic acid)

Also known as: Ascorbic Acid

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

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

Xylitol

non-nutrient/non-botanical

Group: Xylitol

UNII Code: VCQ006KQ1E

Product Statements

Formulation re: Other

Prenatal Multivitamin & Mineral Supplement Capsules

Formula re: Type

Indications: Concept 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. Concept OB may also be used to improve the nutritional status of women before conception.

Precautions re: All Other

Contraindications: Concept 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.

Formula re: Contains

Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All concept 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.

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 re: All Other

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.

Precautions re: All Other

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.

Formulation re: Other

HOW SUPPLIED: Concept OB are pearl red-orange opaque Vcaps capsules printed in white with "Concept OB" on the cap and "US" Logo on the body. Packed in child-resistant cap and light resistant bottle of 30 capsules (52747-0620-30). 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.

Storage

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

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.

Brand IP Statement(s) re: (c), (TM), (SM)

Vcaps and the Vcaps Logo are trademarks used under license.

General Statements: All Other Content

Consult package literature for full prescription information.

Formulation re: Other

Manufactured with Vcaps capsule shells. Manufactured in a FDA registered facility in the USA.

Precautions re: All Other

CAUTION: Rx only.

General Statements: All Other Content

Patent numbers: USA: 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.

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.

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).

Brand IP Statement(s) re: (c), (TM), (SM)

Ferrous Fumarate and Polysaccharide Iron Complex (PIC): All concept products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending).

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