MATERNACEL- beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, magnesium oxide tablet 
Aletris Pharmaceuticals, LLC

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MaternaCel
PRENATAL/POSTNATAL 
Dietary Supplement

MaternaCel-Dispensed by Prescription

MaternaCel- beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, and magnesium oxide tablet.

Serving Size: 1 Tablet

Servings Per Container: 30

Each Tablet Contains:

%DV

Vitamin A (as Beta-Carotene)                     

300 mcg RAE 

23%

Vitamin C (as ascorbic acid) 

60 mg

50%

Vitamin D3 (as cholecalciferol)

10 mcg

67%

Vitamin E (as dl-Alpha-Tocopheryl Acetate)

45 mg

24%

Vitamin B6 (as pyridoxine HCl)

26 mg

1300%

Folate

(From Folic Acid)

(From 5-Methyl Tetrahydrofolate, Calcium Salt)

1670 mcg DFE

278%

 Vitamin B12 (as Cyanocobalamine)

13 mcg

464%

Biotin

28 mg

80%

Calcium (from Calcium Carbonate) 

80 mg

6%

FerrochelTM Iron (as ferrous BisGlycinate Chelate)

12 mg

44%

Iodine (as potassium iodide)

150 mcg

52%

Magnesium (as Magnesium oxide)

25 mg

6%

* -Percent Daily Value for pregnant and/or lactating women

OTHER INGREDIENTS: Modified Cellulose, Stearic Acid, Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol, Polydextrose, Titanium Dioxide, FD&C #1 Blue Lake

Allergen: NONE

DESCRIPTION

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

INDICATIONS

MaternaCel 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 lactating and non-lactating mothers.

CONTRADINDICATIONS

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

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 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.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact: Aletris Pharmaceuticals, LLC at 228-207-8112.

DOSAGE AND ADMINISTRATION

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

PRECAUTION:

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.

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.

image description

MATERNACEL 
beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, magnesium oxide tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)86001089075
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE300 ug
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-45 mg
PYRIDOXINE HCL (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE26 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1670 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN13 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN28 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION80 mg
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION20 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18600108907530 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement12/06/2024
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
shape
scoring1
size (solid drugs)19 mm
Labeler - Aletris Pharmaceuticals, LLC (118956541)
Establishment
NameAddressID/FEIBusiness Operations
Aletris Pharmaceuticals, LLC118956541

Revised: 12/2024
Document Id: dbf1560a-3f5e-4776-8a7c-75f84b89a695
Set id: 7a36fa6d-0130-4d31-b57f-e2db69b4ae81
Version: 2
Effective Time: 20241229
 
Aletris Pharmaceuticals, LLC