NDC | 58657-170-01 |
Set ID | 1f8785db-3e65-49d7-b017-b1a65b5ec6b1 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Method Pharmaceuticals, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
M-Natal Plus tablet
Supplement Facts Serving Size: 1 Tablet Amount Per Serving % Daily Value for Pregnant and Lactating Women Vitamin A (as Acetate and Beta Carotene) 4000 IU 50% Vitamin C (Ascorbic Acid) 120 mg 200% Vitamin D (Vitamin D3 as cholecalciferol) 400 IU 100% Vitamin E (dl-Alpha Tocopheryl Acetate) 22 IU 73% Thiamine (Vitamin B1 from Thiamine Mononitrate) 1.84 mg 108% Riboflavin (Vitamin B2) 3 mg 150% Niacin (Niacinamide) 20 mg 100% Vitamin B6 (as Pyridoxine HCl) 10 mg 400% Folic Acid 1 mg 125% Vitamin B12 (Cyanocobalamin) 12 mcg 150% Calcium 200 mg 15% Iron (Ferrous Fumarate) 27 mg 150% Zinc (Zinc Oxide) 25 mg 167% Copper (Cupric Oxide) 2 mg 100% Other Ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Polyvinyl Alcohol, Stearic Acid, Titanium Dioxide, Polyethylene Glycol, Talc, Magnesium Stearate, Silicon Dioxide, Beet Powder, Caramel, Carnauba Wax.
Close - DESCRIPTION
M-Natal Plus Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner.
Close - DOSAGE AND ADMINISTRATION
Before, during and/or after pregnancy, one tablet daily, with a meal, or as directed by a licensed healthcare practitioner regardless of lactation status.
Close - 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.
Close - CAUTION
High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.
Store at 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.
Call your licensed medical practitioner about side effects. You may report side effects by calling Method at 1-877-250-3427 or FDA at 1-800-FDA-1088.
Close - HOW SUPPLIED
Supplied as beige tablet, imprinted "M170" dispensed in bottles of 100 tablets.
Manufactured By:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118
Rev. 08/2018
Close - PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
M-NATAL PLUS
vitamin a, vitamin c, vitamin d, vitamin e, thiamine, riboflavin, niacin, vitamin b6, folic acid, vitamin b12, calcium, iron, zinc, copper tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-170 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 4000 [iU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D 400 [iU] .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 22 [iU] THIAMINE (UNII: X66NSO3N35) (Thiamine ION - UNII:4ABT0J945J) THIAMINE 1.84 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 10 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM 200 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 25 mg COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 2 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARAMEL (UNII: T9D99G2B1R) CARNAUBA WAX (UNII: R12CBM0EIZ) Product Characteristics Color BROWN (baige) Score no score Shape RECTANGLE (oblong) Size 19mm Flavor Imprint Code M170 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58657-170-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/01/2018 Labeler - Method Pharmaceuticals, LLC (060216698)