FDA Label for Pnv-select
View Indications, Usage & Precautions
Pnv-select Product Label
The following document was submitted to the FDA by the labeler of this product Acella Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Rx Only
OTHER INGREDIENTS: Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein.
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30005
1-800-541-4802
Rev 0719-03
Description
DESCRIPTION: PNV-Select is a prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of a white, oval, oil-and water-soluble, film-coated tablet debossed with “320” on one side.
Indications & Usage
INDICATIONS: PNV-Select is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Boxed Warning
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Precautions
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Adverse Reactions
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage & Administration
DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.
How Supplied
HOW SUPPLIED: PNV-Select is supplied in child-resistant bottles of 90 tablets (42192-320-90). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
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.]
Principal Display Panel - Film Coated Tablets
NDC 42192-320-90
PNV-Select
Prenatal Multivitamin
Dietary Supplement
Film Coated Tablets
Rx Only 90 Tablets
Acella
PHARMACEUTICALS, LLC
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