JENLIVA- ascorbic acid, cholecalciferol, thiamin, vitamin b6, folic acid, methylcobalamin, calcium carbonate, ferrous fumarate,

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Kauptu það núna

Download Vara einkenni (SPC)
03-07-2021

Virkt innihaldsefni:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W), CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB), FERROU

Fáanlegur frá:

Primary Pharmaceuticals, Inc.

Stjórnsýsluleið:

ORAL

Vörulýsing:

Jenliva capsules are available as clear, standard-sized capsules and are available in 30-count bottles (72275-0301-30*). This product is not an Orange Book product. Dispensed by Prescription† Manufactured for: Primary Pharmaceuticals, Inc Ocean Springs, MS 39564 Rev. 10/20 *Primary Pharmaceuticals, Inc 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). 1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. 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)

Leyfisstaða:

Dietary Supplement

Vara einkenni

                                JENLIVA- ASCORBIC ACID, CHOLECALCIFEROL, THIAMIN, VITAMIN B6, FOLIC
ACID,
METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, IODINE CAPSULE
PRIMARY PHARMACEUTICALS, INC.
----------
JENLIVA
HEALTH CLAIM:
Jenliva Capsules - Prenatal/Postnatal Dietary Supplement
Dispensed by Prescription
SUPPLEMENT FACTS
SERVING SIZE: 1 CAPSULE
Serving per Bottle: 30
AMOUNT PER SERVING:
% DAILY VALUE
Vitamin C (Ascorbic Acid)
125 mg
139%
Vitamin D (as Cholecalciferol)
12.5 mcg
63%
Thiamin (as Thiamin HCl)
1.4 mg
117%
Vitamin B6 (as Pyridoxine HCl)
2.5 mg
147%
Folate
1,666 mcg DFE (1000 mcg Folic Acid) 417%
Vitamin B12 (as Methylcobalamin)
1,000 mcg
41,667%
Calcium (from Calcium Carbonate) 200 mg
15%
Iron (as Ferrous Fumarate)
13 mg
72%
Iodine (as Potassium Iodide)
150 mcg
100%
OTHER INGREDIENTS: Hypromellose (Capsule), Rice Flour, and Magnesium
Stearate.
DESCRIPTION:
Jenliva capsules are a prescription dietary supplement for use
throughout pregnancy,
during the postnatal period for both lactating and non-lactating
mothers, and
throughout the childbearing years. Jenliva capules may be useful in
improving the
nutritional status of women prior to conception.
WARNING AND PRECAUTIONS
WARNING: ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING
CAUSE
OF FATAL POISONING IN CHILDREN UNDER 6. KEEP THIS AND ALL DRUGS OUT OF
THE
REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR
POISON
CONTROL CENTER IMMEDIATELY.
CONTRAINDICATIONS:
Jenliva capsules are contraindicated in patients with a known
hypersensitivity to any of
the ingredients. Do not take this product if you are presently taking
mineral oil, unless
directed by a doctor.
PRECAUTION:
Folic acid alone is improper therapy in the treatment of pernicious
anemia and other
megaloblastic anemias where vitamin B is deficient. Folic acid in
doses above 1 mg daily
may obscure pernicious anemia in that hematologic remission can occur
while
neurological manifestations progress. Jenliva capsules should only be
used under the
direction and supervision of a licensed medica
                                
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