FEONYX- ascorbic acid, folic acid, methylcobalamin, ferrous fumarate, zinc citrate tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W), FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR), ZINC CITRATE (UNII: K72I3DEX9B) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Amella Pharma, LLC
Administration route:
ORAL
Therapeutic indications:
FEONYX should not be used by patients with a known hypersensitivity to any of the listed ingredients. All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias. PRECAUTIONS: General: Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and the underlying cause or causes should be determined before starting therapy with FEONYX tablets. Ensure Hgb, Hct, Reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible. Folic Acid: Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. F
Product summary:
FEONYX Tablets are small, round, dark brown, clear-coated tablet, with debossed "A" on one side. FEONYX Tablets is available as the following: 72287-361-28*   28ct   bottle STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light, moisture and avoid excessive heat. Dispense in a tight, light resistant container as defined by the USP using a child-resistant closure. Manufactured for: Amella Pharma, LLC E Brunswick, NJ 08816 Call your doctor for medical advice about side effects. You may report side effects to Amella Pharma, LLC at 1-844-385-0850. Issued: 06/2020 AP10102v1 *Amella Pharma does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies. † This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims. 1. Federal Register Notice of August 2, 1973 (38 FR 20750) 2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044) 3. Federal Register Notice of March 5, 1996 (61 FR 8760)
Authorization status:
Dietary Supplement

Read the complete document

FEONYX- ascorbic acid, folic acid, methylcobalamin, ferrous fumarate, zinc citrate tablet,

coated

Amella Pharma, LLC

----------

FEONYX

Tablets with 150 mg Ferrous Fumarate

HEALTH CLAIM:

FEONYX Tablets Dietary Supplement with Iron

Dispensed by Prescription

Supplements Facts

Serving Size: 1 Tablet

Servings per container: 28

Amount per

Serving

%

Daily

Value

Vitamin C (as Ascorbic Acid)

60 mg

Folate (1 mg Folic Acid)

1666 mcg

417%

Vitamin B12 (as Methylcobalamin)

6 mcg

250%

Iron (as Ferrous Fumarate)

(Equivalent to about 50mg of

Elemental Iron)

150 mg

833%

Zinc (as Zinc Citrate)

15 mg

136%

OTHER INGREDIENTS: Cellulose, Docusate Sodium, Croscarmellose Sodium, Pharmaceutical

Glaze, Calcium Stearate, Povidone, Silicon Dioxide

DESCRIPTION

FEONYX Tablets is a professionally prescribed orally administrated hematinic

multivitamin/multimineral dietary supplement used to improve the nutritional status of patients with iron

deficiency; this includes women prior to conception, throughout pregnancy, and in the postnatal period

for both lactating and non-lactating mothers. THIS PRODUCT IS NOT INDICATED FOR USE IN

CHILDREN.

FEONYX Tablets are small, round, dark brown, clear-coated tablet, with debossed "A" on one side.

CONTRAINDICATIONS

FEONYX should not be used by patients with a known hypersensitivity to any of the listed ingredients.

All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic

anemias.

PRECAUTIONS:

General: Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of

intolerance appear. The type of anemia and the underlying cause or causes should be determined before

starting therapy with FEONYX tablets. Ensure Hgb, Hct, Reticulocyte count are determined before

starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to

determine if it needs to be continued without change or if a dose change is indicated. Since the anemia

may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes

should be corrected, if possible.

Folic Acid: Folic acid alone is an improper therapy in the treatment of pernicious anemia and other

megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may

obscure pernicious anemia assessment, such that hematologic remission can occur while neurological

manifestations remain progressive. Allergic sensitization has been reported following both oral and

parenteral administration of folic acid.

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

considered.

Pediatric Use: Safety and effectiveness in pediatric population have not been established.

Geriatric Use: Safety and effectiveness in elderly population have not been established.

KEEP OUT OF REACH OF CHILDREN.

DRUG INTERACTIONS

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or

fluoroquinolones

ADVERSE REACTIONS

Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting,

and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has

been reported following both oral and parental administration of folic acid.

OVERDOSAGE

The clinical course of acute iron overdosage can be variable. Symptoms may include abdominal pain,

metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular

congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry

stools, melena, hematemesis, hypotension, tachycardia, hyperglycemia, dehydration, drowsiness, pallor,

cyanosis, lassitude, seizures, and shock.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic

anemias where vitamin B

is deficient.

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.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 tablet by mouth once daily or as directed by a physician. Do not chew tablet.

HOW SUPPLIED

FEONYX Tablets are small, round, dark brown, clear-coated tablet, with debossed "A" on one side.

FEONYX Tablets is available as the following:

72287-361-28* 28ct bottle

STORAGE

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP

Controlled Room Temperature]. Protect from light, moisture and avoid excessive heat. Dispense in a

tight, light resistant container as defined by the USP using a child-resistant closure.

Manufactured for:

Amella Pharma, LLC

E Brunswick, NJ 08816

Call your doctor for medical advice about side effects. You may report side effects to Amella Pharma,

LLC at 1-844-385-0850.

Issued: 06/2020 AP10102v1

*Amella Pharma does not represent these product codes to be National Drug Codes (NDC). Product

codes are formatted according to standard industry practice, to meet the formatting requirement by

pedigree reporting and supply-chain control including pharmacies.

† This product is a prescription-folate with or without other dietary ingredients that – due to increased

folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires

administration under the care of a licensed medical practitioner (61 FR 8760). The most appropriate

way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to

dispense this product only by prescription (Rx). This is not an Orange Book product. This product may

be administered only under a physician’s supervision and all prescriptions using this product shall be

pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be

construed to be drug claims.

1. Federal Register Notice of August 2, 1973 (38 FR 20750)

2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)

3. Federal Register Notice of March 5, 1996 (61 FR 8760)

Packaging

FEONYX

ascorbic acid, folic acid, methylcobalamin, ferrous fumarate, zinc citrate tablet, coated

Product Information

Product T ype

DIETARY SUPPLEMENT

Ite m Code (Source )

NHRIC:7228 7-36 1

Serving Size :

Serving per Container :

Amella Pharma, LLC

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R) (ASCORBIC ACID - UNII:PQ6 CK8 PD0 R)

ASCORBIC ACID

6 0 mg

FO LIC ACID (UNII: 9 35E9 7BOY8 ) (FOLIC ACID - UNII:9 35E9 7BOY8 )

FOLIC ACID

1 mg

METHYLCO BALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)

METHYLCOBALAMIN

6 ug

FERRO US FUMARATE (UNII: R5L48 8 RY0 Q) (FERROUS CATION - UNII:GW8 9 58 1OWR)

FERROUS CATION

150 mg

ZINC CITRATE (UNII: K72I3DEX9 B) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

15 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 )

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

SHELLAC (UNII: 46 N10 7B71O)

CALCIUM STEARATE (UNII: 776 XM70 47L)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NHRIC:7228 7-36 1-28

28 in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

dietary supplement

11/18 /20 20

Supplement Facts

Amount Per Serving

% Daily Value

color

shape

size (solid drugs)

11 mm

scoring

imprint

Labeler -

Amella Pharma, LLC (081189492)

Revised: 11/2020

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