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

Calcium

mineral
Forms:
  • Calcium Carbonate
Amount: 200 mg
Serving Size: 1 Tablet(s)

Group: Calcium

Choline

vitamin
Forms:
  • Choline Bitartrate
Amount: 55 mg
Serving Size: 1 Tablet(s)

Group: Choline

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

UNII Code: N91BDP6H0X

Folic Acid

vitamin
Amount: 1 mg
Serving Size: 1 Tablet(s)

Group: Folate

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

UNII Code: 935E97BOY8

Iodine

mineral
Forms:
  • Potassium Iodide
Amount: 150 mcg
Serving Size: 1 Tablet(s)

Group: Iodine

Iron

mineral
Forms:
  • Ferrous Fumarate
Amount: 27 mg
Serving Size: 1 Tablet(s)

Group: Iron

Niacin

vitamin
Forms:
  • Niacinamide
Amount: 20 mg
Serving Size: 1 Tablet(s)

Group: Niacin

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

UNII Code: 2679MF687A

Vitamin B1

vitamin
Forms:
  • Thiamine Mononitrate
Amount: 3 mg
Serving Size: 1 Tablet(s)

Group: Thiamin

Also known as: Thiamin, Thiamine

UNII Code: X66NSO3N35

Forms:
  • Cyanocobalamin
Amount: 8 mcg
Serving Size: 1 Tablet(s)

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B2

vitamin
Forms:
  • Riboflavin
Amount: 3 mg
Serving Size: 1 Tablet(s)

Group: Vitamin B

Vitamin B6

vitamin
Forms:
  • Pyridoxine Hydrochloride
Amount: 50 mg
Serving Size: 1 Tablet(s)

Group: Vitamin B6

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 120 mg
Serving Size: 1 Tablet(s)

Group: Vitamin C (unspecified)

Vitamin D3

vitamin
Forms:
  • Cholecalciferol
Amount: 410 IU
Serving Size: 1 Tablet(s)

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

Vitamin E

vitamin
Forms:
  • DL-Alpha-Tocopheryl Acetate
Amount: 30 IU
Serving Size: 1 Tablet(s)

Group: Vitamin E

Also known as: Sun E 900, Naturall-e, Sunvitol, Sunvitol E500, Delta Gold Tocotrienol

UNII Code: H4N855PNZ1

Zinc

mineral
Forms:
  • Zinc Oxide
Amount: 15 mg
Serving Size: 1 Tablet(s)

Group: Zinc

Group: Gelatin

Group: Calcium

Also known as: Ca Sulfate

UNII Code: WAT0DDB505

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Citric Acid

non-nutrient/non-botanical

Group: Citric Acid

Group: Croscarmellose Sodium

Group: Calcium

Group: Digestion resistant Maltodextrin

Also known as: maltodextrin

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Group: Magnesium stearate

Maltodextrin

complex carbohydrate

Group: Maltodextrin

Also known as: Fibersol-2, DuraCarb

UNII Code: 7CVR7L4A2D

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

Group: Cellulose

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

Group: Hydrogenated Soybean Oil

PEG

other

Group: Polyethylene glycol

Also known as: Polyethylene Glycol

Group: Polyethylene glycol

Also known as: PEG

Group: Polyvinyl alcohol

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

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

Group: Titanium Dioxide

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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