PNV DHA

Product Overview

Brand: Acella Pharmaceuticals

Net Contents: 30 Softgel(s)

Serving Size (Overview): 1 Softgel(s)

Product Type: Other Combinations [A1325]

Form: Softgel Capsule [E0161]

Date Entered: Nov 21, 2020

Market Status: On Market

Suggested Use (Overview): Dosage and administration: Before; during and/or after pregnancy; one softgel daily or as directed by a physician.

Ingredient	Category	Amount Per Serving	Unit	% Daily Value	Target Group	Serving Size (Fact)
Vitamin C	vitamin	85	mg	142	Pregnant and Lactating	1 Softgel(s)
Vitamin C	vitamin	85	mg	142	Adults and children 4 or more years of age	1 Softgel(s)
Vitamin D3	vitamin	200	IU	50	Pregnant and Lactating	1 Softgel(s)
Vitamin D3	vitamin	200	IU	50	Adults and children 4 or more years of age	1 Softgel(s)
Vitamin E	vitamin	10	IU	33	Adults and children 4 or more years of age	1 Softgel(s)
Vitamin E	vitamin	10	IU	33	Pregnant and Lactating	1 Softgel(s)
Folate	vitamin	1	mg	250	Adults and children 4 or more years of age	1 Softgel(s)
Folate	vitamin	1	mg	125	Pregnant and Lactating	1 Softgel(s)
Folic Acid	vitamin	400	mcg	N/A	N/A	1 Softgel(s)
Vitamin B6	vitamin	25	mg	1250	Adults and children 4 or more years of age	1 Softgel(s)
Vitamin B6	vitamin	25	mg	1000	Pregnant and Lactating	1 Softgel(s)
Vitamin B12	vitamin	12	mcg	200	Adults and children 4 or more years of age	1 Softgel(s)
Vitamin B12	vitamin	12	mcg	150	Pregnant and Lactating	1 Softgel(s)
Calcium	mineral	140	mg	14	Adults and children 4 or more years of age	1 Softgel(s)
Calcium	mineral	140	mg	11	Pregnant and Lactating	1 Softgel(s)
Iron	mineral	27	mg	150	Adults and children 4 or more years of age	1 Softgel(s)
Iron	mineral	27	mg	150	Pregnant and Lactating	1 Softgel(s)
Magnesium	mineral	45	mg	11	Adults and children 4 or more years of age	1 Softgel(s)
Magnesium	mineral	45	mg	10	Pregnant and Lactating	1 Softgel(s)
Docosahexaenoic Acid	fatty acid	300	mg	N/A	Adults and children 4 or more years of age	1 Softgel(s)
Docosahexaenoic Acid	fatty acid	300	mg	N/A	Pregnant and Lactating	1 Softgel(s)

Bovine Gelatin; Glycerin; White Beeswax; Vegetable Shortening; Soy Lecithin; purified Water; FD&C Blue No. 1; Titanium Dioxide; FD&C Red No. 3

Rx Only Dietary Supplement Description: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is cobalt blue in color opaque and imprinted with 'BP321' on one side and blank on the other. PNV-DHA can also be beneficial in improving the nutritional status of women prior to conception.

PNV-DHA contains fish oil and soy. Contraindications: PNV-DHA is contraindicated in patients with a known hypersensivity to any of the ingredients. Warning: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited and acquired predisposition to bleeding. 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. 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. Adverse reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Keep this and all medications out of the reach of children.

Indications: PNV-DHA is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

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

How supplied: Bottles of 30 softgels (42192-321-30). The listed product number is not a National Drug Code. Instead Acella Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

Storage: Store at 20 degrees; 25 degrees C (68 degrees; 77 degrees F); excursions permitted to 15 degrees; 30 degrees C (59 degrees; 86 degrees F).[See USP Controlled Room Temperature.]