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

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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)

제공처:

Amella Pharma, LLC

관리 경로:

ORAL

치료 징후:

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

제품 요약:

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)

승인 상태:

Dietary Supplement

제품 특성 요약

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
67%
Folate (1 mg Folic Acid)
1666 mcg
DFE
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
l