<<

PRENATAL PLUS PLUS DHA MINICAPS- a, ascorbic acid, cholecalciferol, tocopherol, mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, carbonate, ferrous fumarate, zinc oxide, cupric oxide, niacinamide, and fish oil Agile RX ------PNV Prenatal Health™ - Prenatal + DHA*

PRENATAL VITAMINS Supplement Facts Serving Size: 1 Tablet Servings Per Container: 30 Amount per % Daily Value serving (from Acetate and Beta Carotene) 4000 IU 50% Vitamin C (Ascorbic Acid) 120 mg 200% Vitamin D-3 (Cholecalciferol) 400 IU 100% Vitamin E (dl-Alpha Tocopheryl Acetate) 22 mg 50% Vitamin B-1 (from Thiamine Mononitrate) 1.84 mg 108% Vitamin B-2 (Riboflavin) 3 mg 150% Niacin (as Niacinamide) 20 mg 100% Vitamin B-6 (from Pyridoxine HCl) 10 mg 400% 1 mg Folic Acid 1700 mcg 212% DFE Vitamin B-12 (Cyanocobalamin) 12 mcg 150% Calcium (as Calcium Carbonate) 200 mg 15% Iron (from Ferrous Fumarate) 27 mg 150% Zinc (from Zinc Oxide) 25 mg 167% Copper (from Cupric Oxide) 2 mg 100% OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Talc and Magnesium Stearate.

DHA* MINICAPS® Supplement Facts Serving Size: 1 MiniCap® Servings Per Container: 30 Amount per % Daily Value serving Calories 5 Calories from Fat 5 Total Fat 0.4 g 3% Saturated Fat 0 g 0% Polyunsaturated Fat <2 mg † Monounsaturated Fat 3 IU † Cholesterol <2 mg 0% Vitamin E 3 IU 10% Total Omega-3 Fatty Acids 312 mg † DHA*(Docosahexaenoic Acid) 250 mg † *Refers to Percent daily Value (%DV) based on a 2000 calorie diet. *DHA as Ethyl Esters †Daily Value not established. OTHER INGREDIENTS: Fish Oil, Gelatin, Water, Glycerin, Orange Oil and Mixed Tocopherols.

PNV Prenatal Plus Multivitamin tablets and DHA* MiniCaps® are formulated to provide vitamin and mineral supplementation throughout and during the postnatal period, for both lactating and non-lactating mothers, and are useful for improving nutritional status prior to conception.‡ In addition, the vital fatty acids in DHA* support brain, eye and nervous system development of your unborn child.‡ Safe easy-to-swallow MiniCaps® have no fishy odor or aftertaste.

DOSAGE AND ADMINISTRATION Before, during and after pregnancy, swallow 1 PNV Plus tablet and 1 DHA* MiniCap® SoftGel daily, or as directed by a physician.

TAMPER EVIDENT FEATURE Do not use if inner-seal beneath cap is missing or broken.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

CAUTION Folic Acid may mask the symptoms of hematological damage due to Vitamin B12 deficiency of pernicious anemia while the associated neurological damage progresses.

Other Information To report a serious adverse event or obtain product information call 1-888-750-5290. Store at controlled room temperature 15º-30ºC (59º-86ºF). Protect from excess heat and moisture. Dispense in a tight, light-resistant container with a child-resistant closure. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy- level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA. †The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

‡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.

LOT/EXP Manufactured for: Agile RX LLC Boynton Beach, FL 33437 (888) 750-5290 REV 05/05/19 Manufactured in the USA

PRINCIPAL DISPLAY PANEL - Kit Carton 44946-2001-6 PNV Prenatal Health PNV Prenatal Vitamins Prenatal Plus MULTIVITAMIN Tablets + DHA* MINICAPS® Dispense under a physician's order† Provides vitamin and mineral supplementation throughout pregnancy and postnatal period‡ Dietary Supplement Mercury Free Sugar & Gluten Free UNIT DOSE PACK 30 TABLETS AND 30 MINICAPS®

PRENATAL PLUS MULTIVITAMIN PLUS DHA MINICAPS vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, niacinamide, and fish oil kit

Product Information Product T ype DIETARY SUPPLEMENT Ite m Code (Source ) NHRIC:449 46 -20 0 1

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:449 46 -20 0 1-6 1 in 1 CARTON

Quantity of Parts Part # Package Quantity Total Product Quantity Pa rt 1 1 BLISTER PACK 30 Pa rt 2 1 BLISTER PACK 30

Part 1 of 2 PRENATAL PLUS MULTIVITAMIN vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, and niacinamide tablet

Product Information Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE (UNII: 3LE3D9 D6 OY) (VITAMIN A - UNII:8 1G40 H8 B0 T) VITAMIN A 20 0 0 [iU] .BETA.-CARO TENE (UNII: 0 1YAE0 3M7J) (.BETA.-CAROTENE - UNII:0 1YAE0 3M7J) .BETA.-CAROTENE 20 0 0 [iU] ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R) (ASCORBIC ACID - UNII:PQ6 CK8 PD0 R) ASCORBIC ACID 120 mg CHO LECALCIFERO L (UNII: 1C6 V77QF41) (CHOLECALCIFEROL - UNII:1C6 V77QF41) CHOLECALCIFEROL 40 0 [iU] .ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 ) (.ALPHA.-TOCOPHEROL, .ALPHA.-TOCOPHEROL, 22 mg DL- - UNII:7QWA1RIO0 1) DL- THIAMINE MO NO NITRATE (UNII: 8 K0 I0 49 19 X) (THIAMINE ION - UNII:4ABT0 J9 45J) THIAMINE 1.8 4 mg RIBO FLAVIN (UNII: TLM29 76 OFR) (RIBOFLAVIN - UNII:TLM29 76 OFR) RIBOFLAVIN 3 mg PYRIDOXINE PYRIDO XINE HYDRO CHLO RIDE (UNII: 6 8 Y4CF58 BV) (PYRIDOXINE - UNII:KV2JZ1BI6 Z) 10 mg HYDROCHLORIDE FO LIC ACID (UNII: 9 35E9 7BOY8 ) (FOLIC ACID - UNII:9 35E9 7BOY8 ) FOLIC ACID 1 mg CYANO CO BALAMIN (UNII: P6 YC3EG20 4) (CYANOCOBALAMIN - UNII:P6 YC3EG20 4) CYANOCOBALAMIN 12 ug CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) (CALCIUM CATION - UNII:2M8 3C4R6 ZB) CALCIUM CARBONATE 20 0 mg FERRO US FUMARATE (UNII: R5L48 8 RY0 Q) (FERROUS CATION - UNII:GW8 9 58 1OWR) FERROUS CATION 27 mg ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37) ZINC CATION 25 mg CUPRIC O XIDE (UNII: V1XJQ70 4R4) (CUPRIC CATION - UNII:8 CBV6 7279 L) CUPRIC CATION 2 mg NIACINAMIDE (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4) NIACINAMIDE 20 mg

Inactive Ingredients Ingredient Name Strength CRO SCARMELLO SE (UNII: 0 29 TFK9 9 2N) MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BLISTER PACK

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date Dietary Supplement 11/15/20 16

Part 2 of 2 DHA MINICAPS fish oil capsule

Product Information Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FISH O IL (UNII: XGF7L72M0 F) (FISH OIL - UNII:XGF7L72M0 F) FISH OIL 312 mg Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L) WATER (UNII: 0 59 QF0 KO0 R) GLYCERIN (UNII: PDC6 A3C0 OX) O RANGE O IL (UNII: AKN3KSD11B) TO CO PHERO L (UNII: R0 ZB2556 P8 )

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BLISTER PACK

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date Dietary Supplement 11/15/20 16

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date Dietary Supplement 11/15/20 16

Labeler - Agile RX (116742427)

Revised: 6/2019 Agile RX