Thrivite 19

THRIVITE 19- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium tablet, coated
Method Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Thrivite 19 Tablets

Vitamins & Minerals with Folic Acid

R x

DESCRIPTION

Thrivite 19 provides oil soluble vitamins, water-soluble vitamins and minerals.

Each tablet contains:

Vitamin A (as beta carotene) ……………………………………………. 1000 IU

Vitamin C (ascorbic acid) ………………………………………………….. 100 mg

Vitamin D (as cholecalciferol) …………………………………………….. 400 IU

Vitamin E (as dl-alpha tocopheryl acetate) ………………………………. 30 IU

Thiamine (Vitamin B1) ………………………………………………………… 3 mg

Riboflavin (Vitamin B2) ………………………………………………………. 3 mg

Niacin (as niacinamide) …………………………………………………….. 15 mg

Vitamin B6 (as pyridoxine HCI) …………………………………………… 20 mg

Folate (folic acid) ………………………………………………………………. 1 mg

Vitamin B12 (as cyanocobalamin) ……………………………………….. 12 mcg

Pantothenic Acid (as calcium pantothenate) …………………………….. 7 mg

Calcium (as calcium carbonate) …………………………………………. 200 mg

Iron (as ferrous fumarate) …………………………………………………. 29 mg

Zinc (as zinc oxide) …………………………………………………………… 20 mg

Docusate Sodium ……………………………………………………………… 25 mg

OTHER INGREDIENTS

Microcrystalline Cellulose, Hypromellose, Titanium Dioxide, Polyvinyl Alcohol, Polyethylene Glycol, Talc, Croscarmellose Sodium, Fumed Silica, Stearic Acid, Magnesium Stearate, Gum Arabic.

INDICATIONS

Thrivite 19 Tablets are indicated to provide B-vitamin supplementation and may be used in conjunction with a physician prescribed prenatal regimen.

CONTRAINDICATIONS

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

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal pois oning 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

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse Reactions to Thrivite 19

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

DOSAGE AND ADMINISTRATION

One or two tablets daily, in divided doses, or as directed by a physician.

HOW SUPPLIED

Bottles of 100 tablets (NDC 58657-136-01).

Thrivite 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed “M136″, packaged in bottles of 100 tablets.

STORAGE

Store at room temperature, USP. Protect from moisture and excessive heat.

Avoid freezing.

PHARMACIST

Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistant closure.

Call your doctor about side effects. You may report side effects to

FDA at 1-800-FDA-1088.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

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

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Manufactured For:
Method Pharmaceuticals, LLC

Arlington, TX 76006
1-877-250-3427
Rev. 06/15

PRINCIPAL DISPLAY PANEL

NDC 58657-136-01
Thrivite 19
Tablets

Rx

100 Tablets

PRINCIPAL DISPLAY PANEL
NDC 58657-136-01
Thrivite 19
Tablets
Rx
100 Tablets
(click image for full-size original)
THRIVITE 19
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 1000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
THIAMINE (Thiamine ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 15 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID and CALCIUM CATION) PANTOTHENIC ACID 7 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 29 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 20 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOLS
TALC
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
STEARIC ACID
MAGNESIUM STEARATE
ACACIA
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (oblong) Size 19mm
Flavor Imprint Code M136
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-136-01 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/15/2015
Labeler — Method Pharmaceuticals, LLC (060216698)

Revised: 06/2015 Method Pharmaceuticals, LLC

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