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NDC 59088-0525-54 Multitam 30; 120; 200; 20; 35; 8; 1000; 200; 2.3; 45; 20; 20; 3.4; 55; 3; 1500; 25 mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1 Details

Multitam 30; 120; 200; 20; 35; 8; 1000; 200; 2.3; 45; 20; 20; 3.4; 55; 3; 1500; 25 mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1

Multitam is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CHROMIUM NICOTINATE; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM OXIDE; MANGANESE SULFATE; MOLYBDENUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONO.

Product Information

NDC	59088-0525
Product ID	59088-525_d825970d-7bf4-c79f-e053-2995a90a6103
Associated GPIs	78310000000300
GCN Sequence Number	081683
GCN Sequence Number Description	multivit-min no.86/folic acid TABLET 1000 MCG ORAL
HIC3	C6Z
HIC3 Description	MULTIVITAMIN PREPARATIONS
GCN	48875
HICL Sequence Number	046971
HICL Sequence Number Description	MULTIVITAMIN WITH MINERALS NO.86/FOLIC ACID
Brand/Generic	Brand
Proprietary Name	Multitam
Proprietary Name Suffix	n/a
Non-Proprietary Name	Folic Acid
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	30; 120; 200; 20; 35; 8; 1000; 200; 2.3; 45; 20; 20; 3.4; 55; 3; 1500; 25
Active Ingredient Units	mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CHROMIUM NICOTINATE; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM OXIDE; MANGANESE SULFATE; MOLYBDENUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONO
Labeler Name	PureTek Corporation
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagul
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59088-0525-54 (59088052554)

Pricing Information	N/A
NDC Package Code	59088-525-54
Billing NDC	59088052554
Package	30 TABLET in 1 BOTTLE, PLASTIC (59088-525-54)
Marketing Start Date	2022-01-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cee15842-4a9e-c6ba-e053-2a95a90aebc5 Details

DESCRIPTION:

Each caplet contains:

Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU)

Vitamin C (as ascorbic acid)……………………………… 120 mg

Vitamin D3 (as cholecalciferol)…………………. 20 mcg (800 IU)

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

Thiamin (as thiamine mononitrate)………………………… 3 mg

Riboflavin (vitamin B2)……………………………………. 3.4 mg

Niacin (as niacinamide)…………………………………… 20 mg

Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg

Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)

Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg

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

Magnesium (as magnesium oxide)……………………… 200 mg

Zinc (as zinc oxide)……………………………………….. 25 mg

Selenium (as selenium amino acid chelate)………………. 55 mcg

Manganese (as manganese sulfate)……………………… 2.3 mg

Chromium (as chromium polynicotinate)……………….. 35 mcg

Molybdenum (as molybdenum amino acid chelate)……… 45 mcg

Other Ingredients:

Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).

INDICATIONS:

Multitam™ is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

CONTRAINDICATIONS:

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

WARNING:

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

PRECAUTIONS:

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

There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B 12 may

prevent, halt, or improve the neurologic changes caused by pernicious anemia.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call PureTek Corporation

at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions:

Multitam™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel).

Adverse Reactions:

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

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

DOSAGE AND ADMINISTRATION:

One (1) Multitam™ caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

HOW SUPPLIED:

Multitam™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-525-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Storage

Do not use if bottle seal is broken.

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

Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP].

Protect from light and moisture and avoid excessive heat.

To report a serious adverse event or to obtain product information, contact

877-921-7873.

Multitam

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873

INGREDIENTS AND APPEARANCE

MULTITAM

folic acid tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:59088-525
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	30 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	200 mg
CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1)	CHROMIUM NICOTINATE	35 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	20 mg
MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U)	MOLYBDENUM	45 ug
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	55 ug
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	20 ug
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	8 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1500 ug
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 mg
MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE CATION (2+)	2.3 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCOA (UNII: D9108TZ9KG)
CROSPOVIDONE (UNII: 2S7830E561)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	yellow (Beige speckled caplet)	Score	no score
Shape	CAPSULE (Oblong Caplet)	Size	19mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59088-525-54	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/17/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/17/2022

Labeler - PureTek Corporation (785961046)

Revised: 2/2022

Document Id: d825970d-7bf4-c79f-e053-2995a90a6103

Set id: cee15842-4a9e-c6ba-e053-2a95a90aebc5

Version: 2

Effective Time: 20220216