PREGENNA- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, biotin, folic acid, levomefolate calcium, cyanocobalamin, calcium carbonate, magnesium oxide, ferrous bisglycinate, and potassium iodide tablet

PreGenna by

Drug Labeling and Warnings

PreGenna by is a Other medication manufactured, distributed, or labeled by Redmont Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

71741-072-30

Prenatal/Postnatal Dietary Supplement

Dispensed by Prescription

DESCRIPTION

PreGenna is a prescription prenatal/postnatal multivitamin/multimineral dietary supplement.

STATEMENT OF IDENTITY

Supplement Facts
Serving Size: 1 Tablet
Amount per Serving		% Daily Value
** Daily Value not established.
Vitamin A (as Beta-Carotene)	300 mcg RAE	33%
Vitamin C (as Ascorbic Acid)	60 mg	67%
Vitamin D (as Cholecalciferol)	10 mcg	50%
Vitamin E (as dl-Alpha Tocopherol Acetate)	4.5 mg (10 IU)	33%
Vitamin B6 (as Pyridoxine HCl)	26 mg	1529%
Biotin	0.280 mg	933%
Folate	1.67 mg DFE	418%
(from Folic Acid)	0.67 mg DFE
(from 5-Methyl Tetrahydrofolate, Calcium Salt)	1 mg DFE
Vitamin B12 (as Cyanocobalamin)	0.013 mg	542%
Calcium (as Calcium Carbonate)	80 mg	6%
Magnesium (as Magnesium Oxide)	25 mg	6%
Ferrochel™ Iron (as Ferrous BisGlycinate Chelate)	20 mg	111%
Iodine (as Potassium Iodide)	0.150 mg	100%

OTHER INGREDIENTS: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silicon Dioxide, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue # 1)

Allergen: NONE

INDICATIONS

PreGenna is a multivitamin/multimineral dietary supplement indicated for the use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactation on nonlactating mothers.

PreGenna can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

PreGenna is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the 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.

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one tablet daily or as directed by a physician.

HOW SUPPLIED

Bottles of 30 tablets (71741-072-301). Tablet is light blue, oblong.

This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (64 FR 8760). 1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statues as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)

1 Redmont Pharmaceuticals does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

STORAGE AND HANDLING

STORAGE

Store at 20°-25° C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light and moisture.

TAMPER EVIDENT

Do not use if seal is broken or missing.

HEALTH CLAIM

MADE IN USA

Distributed by:
Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909

Ferrochel™ is a trademark of Albion Laboratories, Inc.

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.

KEEP THIS AND ALL MEDICATIONS OF THE REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

71741-072-30

PreGenna

PRENATAL/POSTNATAL
Dietary Supplement

30 TABLETS

Dispensed by Prescription

INGREDIENTS AND APPEARANCE

PREGENNA 
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, biotin, folic acid, levomefolate calcium, cyanocobalamin, calcium carbonate, magnesium oxide, ferrous bisglycinate, and potassium iodide tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71741-072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Beta Carotene (UNII: 01YAE03M7J) (Beta Carotene - UNII:01YAE03M7J)	Beta Carotene	300 ug
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	10 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	4.5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	26 mg
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04)	Biotin	0.280 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	0.400 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLATE CALCIUM	0.600 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	0.013 mg
Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium Carbonate	80 mg
Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium Oxide	25 mg
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (Ferrous Cation - UNII:GW89581OWR)	Ferrous Cation	20 mg
Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q)	Potassium Iodide	0.150 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
Maltodextrin (UNII: 7CVR7L4A2D)
Croscarmellose Sodium (UNII: M28OL1HH48)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Stearic Acid (UNII: 4ELV7Z65AP)
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Titanium Dioxide (UNII: 15FIX9V2JP)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71741-072-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		09/12/2019

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	19 mm

Labeler - Redmont Pharmaceuticals, LLC (080843607)