Multi-Vitamin/Mineral Tablets

Basic Information

Product Label

Product label for Multi-Vitamin/Mineral Tablets
Full Name: Multi-Vitamin/Mineral Tablets
Brand: Gesticare
Product Type: Multi-Vitamin and Mineral (MVM)
Physical State: Tablet or Pill
UPC/SKU: 3 18860 25330 7
Product Version Code: GDHA1-11-04

Contact Information

Manufactured by

Name: PureTek Corporation
Address:San Fernando, CA, 91340
Types: Manufacturer

Distributed by

Name: Azur Pharma, Inc.
Address:1818 Market Street, Suite 2350, Philadelphia, PA, 19103
Types: Distributor

For full product information refer to

Types: Other

Product Details

Net Contents

6 Blister Card(s)(6 Blister Card(s))
30 Count(30 Count)

Serving Sizes

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

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Group: Gelatin

CalcIum

mineral

Group: Calcium

Group: Calcium

Also known as: Ca Sulfate

UNII Code: WAT0DDB505

Choline

vitamin

Group: Choline

Also known as: ch-OSA, VitaCholine, CDP-Choline

UNII Code: N91BDP6H0X

Group: Digestion Resistant Maltodextrin

Fibersol®2 is a soluble fiber derived from maltodextrin that is designed to resist digestion in the small intestine, allowing it to reach the large intestine where it can provide various health benefits. It is often used as a dietary fiber supplement to support digestive health and improve bowel regularity.

Also known as: Digestion Resistant Maltodextrin

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

iodine

mineral

Group: Iodine

Maltodextrin

Complex Carbohydrate

Group: Maltodextrin

Maltodextrin is a polysaccharide that is commonly used as a food additive. It is produced from starch through partial hydrolysis and is often used as a thickener or filler in processed foods. Maltodextrin is easily digestible and can provide a quick source of energy, making it popular in sports drinks and supplements.

Also known as: Maltodextrin, Dextrin, Maltodextrin Powder

UNII Code: null

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

Niacin

vitamin

Group: Niacin

Also known as: Vitamin B3, Vit. B-3, B3, Niacinol, Nicotinic Acid, B-3, Vitamin B-3

UNII Code: 2679MF687A

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B2

Group: Vitamin B1 (Thiamine)

Also known as: Vitamin B1

Group: Hydrogenated Soybean Oil

PEG

other

Group: Polyethylene glycol

Also known as: Polyethylene Glycol

Group: Polyethylene glycol

Also known as: PEG, Macrogol

UNII Code: 3WJQ0SDW1A

Group: Polyvinyl alcohol

Also known as: PVA

UNII Code: 3WJQ0SDW1A

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

Group: Silicon

Also known as: SiO2

UNII Code: ETJ7Z6XBU4

Starch

complex carbohydrate

Group: Starch

UNII Code: 0

Stearic Acid

fatty acid

Group: Stearic Acid

Also known as: C18:0

UNII Code: 4ELV7Z65AP

Sucrose

sugar

Group: Sucrose

UNII Code: C151H8M554

talc

other

Group: Magnesium Silicate

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 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

Product Statements

Precautions re: All Other

Precautions: Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Precautions re: Allergies

Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Suggested/Recommended/Usage/Directions

Dosage and Administration: One Gesticare(R) tablet and one DHA capsule daily or as directed by a physician.

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

How Supplied: Gesticare(R) DHA is supplied as six child-resistant blister cards containing 5 Gesticare(R) tablets and 5 DHA capsules each - NDC 18860-253-30.

Precautions re: All Other

Do not use if blister seal is broken.

Precautions re: Children

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Storage

Store at controlled room temperature 20(0)-25(0)C (68(0)-77(0)F); excursions permitted to 15(0)- 30(0)C (59(0)- 86(0)F).

General Statements: All Other Content

NDC 18860-253-30 (30 count) 6 blister cards; each containing 5 tablets and 5 capsules

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

Description: Gesticare(R) DHA includes a light pink coated oblong-shaped tablet with "P-114" embossed on one side of the tablet and a natural DHA softgel capsule containing a pale orange oil.

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

life'sDHA is a trademark of Martek Biosciences Corporation.

General Statements: All Other Content

GDHA1-11-03

General Statements: All Other Content

PHYSICIAN'S SAMPLES (NDC 18860-253-00)

General Statements: All Other Content

GDHA1-11-04

Suggested/Recommended/Usage/Directions

One tablet and one capsule daily or as directed by physician

General Statements: All Other Content

Contains 6 Patient Starter packages, each containing 2 tablets and 2 capsules

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

Gesticare(R) is a registered trademark of Azur Pharma International II Limited. life's DHA(RM) is a trademark of Martek Biosciences Corporation.

Formula re: Type

Prenatal Multi-vitamin/Mineral Tablets with DHA and Choline

Formula re: Contains

Prenatal Multi-vitamin/Mineral Tablets with DHA and Choline

General Statements: All Other Content

Not for Sale - Rx Only

Seals/Symbols

life's DHA(TM) HEALTHY BRAIN, EYES, HEART

Formula re: Type

Indications and Usage: Gesticare(R) DHA is indicated to provide vitamin/mineral and DHA omega-3 fatty acid supplement to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Gesticare(R) DHA may be beneficial in improving the nutritional status of women prior to conception.

Precautions re: All Other

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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

Warnings: Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

Precautions re: Pregnant or Nursing or Prescription Medications

Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

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