M-NATAL PLUS- vitamin a, vitamin c, vitamin d, vitamin e, thiamine, riboflavin, niacin, vitamin b6, folic acid, vitamin b12, calcium, iron, zinc, copper tablet

M-Natal Plus by

Drug Labeling and Warnings

M-Natal Plus by is a Prescription medication manufactured, distributed, or labeled by Method Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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.

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.

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.

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

PRINCIPAL DISPLAY PANEL

NDC: 58657-170-01
M-Natal Plus
tablet
PRENATAL/POSTNATAL
100 Tablets
Rx Only

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 tablet

Product 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 GLYCOL, UNSPECIFIED (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)