PNV-First (.beta.-carotene 1100 [iu] ascorbic acid 30 mg cholecalciferol 1000 [iu] .alpha.-tocopherol acetate, dl- 20 [iu] thiamine mononitrate 1.6 mg riboflavin 1.8 mg niacinamide 15 mg folic acid 1 mg pyridoxine hydrochloride 2.5 mg cyanocobalamin 12 ug iron sucrose 29 mg potassium iodide 150 ug magnesium oxide 20 mg zinc oxide 25 mg cupric oxide 2 mg omega-3 fatty acids 200 mg) Dailymed

Rx Only

Description Section

Description: PNV-First is a prescription prenatal dietary supplement that contains multivitamins and minerals, which are delivered in a dark amber, oval-shaped softgel capsule imprinted with “350” on one side.

SUPPLEMENT FACTS Each Softgel Contains

Vitamin A (as beta-carotene)	1100IU
Vitamin C (as ascorbic acid)	30 mg
Vitamin D 3 (as cholecalciferol)	1000 IU
Vitamin E (as dl-alpha tocopheryl acetate)	20 IU
Thiamin mononitrate (Vitamin B 1)	1.6 mg
Riboflavin (Vitamin B 2)	1.8 mg
Niacin (as niacinamide)	15 mg
Folic Acid	1 mg
Vitamin B 6 (as pyridoxine HCl)	2.5 mcg
Vitamin B 12 (as cyanocobalamin)	12 mcg
Elemental Iron (as polysaccharide iron complex)	29 mg
Iodine (as potassium iodide)	150 mcg
Magnesium (as magnesium oxide)	20 mg
Zinc (as zinc oxide)	25 mg
Copper (as copper oxide)	2 mg
Omega-3 Fatty Acid DHA from Algal Oil	200 mg

INACTIVE INGREDIENT SECTION

Other Ingredients: bovine gelatin, caramel, glycerin, lecithin, purified water and white beeswax.

Indications & Usage Section

Indications and Usage: PNV-First is indicated to provide vitamin, mineral and omega-3 fatty acid dietary supplementation prior to conception, throughout pregnancy and during the postnatal period for the lactating and non-lactating mother, including individuals with know allergies to fish. PNV-First does not contain fish, fish oils, fish proteins or fish byproducts.

Contraindications Section

Contraindications: PNV-First is contraindicated in patients with hypersensitivity to any of its ingredients. Folic Acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage desease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyrodoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B ₁₂).

Boxed Warning Section

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.

Warnings And Precautions Section

Warnings and Precautions: PNV-First should be used with caution in those with known sensitivity or allergy to soy. Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperthyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure and increased risk of heart disease can occur.

Iodine should be used with caution in patients with an overactive thyroid.

Prolonged use of iron salts may produce iron storage disease. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B ₁₂ deficiency.

Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid Overdosage.

Drug Interactions Section

Drug Interactions: Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High dosages of folic acid may result in decreased serum levels of the anticonvulsant drugs: carbamazapine, fosphenytoin, phenyltoin, phenoberbitol, valproic acid. Folic acid may decrease a patient’s response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Zinc can inhibit the absorption of certain antibiotics. Take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions.

Information For Patients Section

Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy and breast-feeding.

Pediatric Use Section

Pediatric Use: Not recommended for pediatric use.

Adverse Reactions Section

Adverse Reactions: Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in PNV-First. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities and visual problems.

Dosage & Administration Section

Dosage and Administration: Before, during and after pregnancy, one softgel daily, or as directed by a physician.

How Supplied Section

How Supplied: PNV-First is available as a dark amber, oval shaped softgel capsule imprinted with “350” on one side. PNV-First is supplied in child-resistant bottles of 30 softgels (42192-350-30).

The uled product number is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Store at room temperature, approximately 15° - 30°C (59° - 86°F). Avoid excessive heat.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please 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 30022 1-800-541-4802

Rev 0513

Principal Display Panel - 30 Softgels

42192-350-30

PNV-First

All-In-One, Once Daily Softgel Capsule Dietary Supplement

Rx Only        30 Softgels

Acella PHARMACEUTICALS, LLC