HEMAX- ascorbic acid, dl-alpha tocopheryl acetate, l-5-methyltetrahydrofolate calcium, cyanocobalamin, biotin, carbonyl iron, cupric sulfate tablet

HEMAX by

Drug Labeling and Warnings

HEMAX by is a Other medication manufactured, distributed, or labeled by Pronova Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Serving Size: 1 Tablet / Servings Per Container: 90
	Amount	% Daily
	Per Serving	Value
Vitamin C (as Ascorbic Acid)	500 mg	556%
Vitamin E (as dl-Alpha Tocopheryl Acetate)	13.5 mg	90%
Folate (as L-5-methyltetrahydrofolate Calcium)	1,700 mcg DFE	425%
	(1,000 mcg Folic Acid)
Vitamin B12 (as Cyanocobalamin)	60 mcg	2,500%
Biotin	150 mcg	500%
Iron (as Carbonyl Iron)	150 mg	833%
Copper (as Cupric Sulfate)	3 mg	333%
*Daily Value not established

OTHER INGREDIENTS: Microcrystalline Cellulose, Citric Acid, Stearic Acid, Dicalcium Phosphate, Croscarmellose Sodium, Polyvinylpyrrolidone, Magnesium Stearate, Silicon Dioxide, Starch, Glucose Syrup, Crospovidone, Polyethylene Glycol, Talc, Sodium Lauryl Sulfate, FD&C Yellow #6 Lake, Sucrose, Titanium Dioxide, Soy Polysaccharide, FD&C Red #40 Lake, Artificial French Vanilla Flavor, Propylene Glycol and Tricalcium Phosphate. Contains: Soy, a bioengineered food ingredient.

HEMAXTM is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.†

†This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

WARNINGS

WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

DO NOT USE HEMAXTM for individuals with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy. This product is not for use in children under 12 years of age.

WARNING: Consuming this product can expose you to chemicals including, lead and mercury, which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.

PRECAUTIONS

CAUTION: This product contains 1.7mg DFE (1mg) of folic acid, the maximum safe Reference Daily Intake (RDI) amount for this nutrient. Folic Acid alone should not be used for individuals with pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in amounts above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Pregnant women, nursing mothers or women prior to conception who take HEMAXTM should take this supplement only after their medical condition and other drugs, herbs and/or supplements consumption are considered. Use for elderly individuals should be cautious due to the greater frequency of decreased hepatic, renal, or cardiac function.

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

DOSAGE & ADMINISTRATION

DIRECTIONS FOR USE: One tablet daily with or without food or as recommended by your healthcare provider.

SAFE HANDLING WARNING

OTHER INFORMATION: HEMAXTM is supplied in child-resistant bottles of 90, 30 and 4 tablets. Store at room temperature, USP.

To report a serious adverse event or to obtain product information, contact (866) 703-3508.

Manufactured in the USA for:

Pronova Corporation
Miami, Florida 33155

HEALTH CLAIM

Dietary Supplement

With 100% Bioactive Folate

EZY-DOSE TABLETS

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Packaging

INGREDIENTS AND APPEARANCE

HEMAX 
ascorbic acid, dl-alpha tocopheryl acetate, l-5-methyltetrahydrofolate calcium, cyanocobalamin, biotin, carbonyl iron, cupric sulfate tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:67555-130
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	500 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	13.5 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLATE CALCIUM	1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	60 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	150 ug
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	150 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	3 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STEARIC ACID (UNII: 4ELV7Z65AP)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, RICE (UNII: 4DGK8B7I3S)
CORN SYRUP (UNII: 9G5L16BK6N)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SOYBEAN COTYLEDON CELL WALL POLYSACCHARIDES (UNII: 4UL6DF56YQ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:67555-130-30	30 in 1 BOTTLE
2	NHRIC:67555-130-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/19/2023

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	21 mm
scoring	3
imprint
flavor

Labeler - Pronova Corporation (111421496)