Jenliva: Package Insert and Label Information

JENLIVA- ascorbic acid, cholecalciferol, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, methylcobalamin, calcium carbonate, ferrous fumarate and potassium iodide capsule
Primary Pharmaceuticals, Inc.

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:

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 pois on 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 medical practitioner.

ADVERSE REACTIONS:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling the FDA at 1-800-FDA-1088.

DOSAGE & ADMINISTRATION:

Usual adult dose is 1 capsule taken orally once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

Jenliva capsules are available as clear, standard-sized capsules and are available in 30-count bottles (72275-301-30*). 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).

STORAGE AND HANDLING:

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture. Tamper Evident: Do not use if seal is broken or missing.

Distributed by: Primary Pharmaceuticals, Inc , Ocean Springs, MS 39564

PRINCIPAL DISPLAY PANEL

Jenliva

Prenatal/Postnatal

Dietary Supplement

Label
(click image for full-size original)
JENLIVA
ascorbic acid, cholecalciferol, thiamin, vitamin b6, folic acid, methylcobalamin, calcium carbonate, ferrous fumarate, iodine capsule
Product Information
Product Type Item Code (Source) NDC:72275-301
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 125 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 0.0125 mg
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 1.4 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 2.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 1 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 13 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 0.15 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
BROWN RICE
MAGNESIUM STEARATE
Product Characteristics
Color white (clear) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72275-301-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 11/06/2020
Labeler — Primary Pharmaceuticals, Inc. (066126126)

Revised: 04/2021 Primary Pharmaceuticals, Inc.

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