Label: JENLIVA- ascorbic acid, cholecalciferol, thiamin, vitamin b6, folic acid, methylcobalamin, calcium carbonate, ferrous fumarate, iodine capsule
- NHRIC Code(s): 72275-301-30
- Packager: Primary Pharmaceuticals, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated July 3, 2021
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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.
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.
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 medical practitioner.
- DOSAGE & ADMINISTRATION:
HOW SUPPLIED HEALTH CLAIM:
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
*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)
- STORAGE AND HANDLING:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ascorbic acid, cholecalciferol, thiamin, vitamin b6, folic acid, methylcobalamin, calcium carbonate, ferrous fumarate, iodine capsule
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:72275-301 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 125 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 0.0125 mg THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 1.4 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 2.5 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 1 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 13 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 0.15 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) BROWN RICE (UNII: 659G217HPG) MAGNESIUM STEARATE (UNII: 70097M6I30) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:72275-301-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 11/06/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 23 mm scoring 1 Labeler - Primary Pharmaceuticals, Inc. (066126126)