Jenliva Capsules - Prenatal/Postnatal Dietary Supplement

Dispensed by Prescription

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 poison control center immediately.

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.

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

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)

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.

Jenliva

Prenatal/Postnatal

Dietary Supplement