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PNV-First

Generic Name: prenatal multivitamins and minerals
Dosage Form: tablet, coated/softgel capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

PNV - First

Rx Only

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 D3 (as cholecalciferol) 1000 IU
Vitamin E (as dl-alpha tocopheryl acetate) 20 IU
Thiamin mononitrate (Vitamin B1) 1.6 mg
Riboflavin (Vitamin B2) 1.8 mg
Niacin (as niacinamide) 15 mg
Folic Acid 1 mg
Vitamin B6 (as pyridoxine HCl) 2.5 mcg
Vitamin B12 (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

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

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: 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 B12).

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: 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 B12 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: 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: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy and breast-feeding.

Pediatric Use: Not recommended for pediatric use.

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

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 listed 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

PNV-First 
.beta.-carotene, cholecalciferol, ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, niacinamide, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide, cupric oxide and doconexent tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42192-350
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 1100 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 30 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1000 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 20 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.6 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.8 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 15 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 2.5 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
IRON SUCROSE (FERRIC CATION) FERRIC CATION 29 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 20 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 200 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
CARAMEL  
GLYCERIN  
LECITHIN, SOYBEAN  
WATER  
YELLOW WAX  
Product Characteristics
Color RED (dark amber) Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 350
Contains         
Packaging
# Item Code Package Description
1 NDC:42192-350-30 30 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/17/2013
Labeler - Acella Pharmaceuticals, LLC (825380939)
Revised: 06/2013
 
Acella Pharmaceuticals, LLC



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