M-natal Plus

M-natal Plus
SPL v103
SPL
SPL Set ID f9f15374-4809-4b96-8a07-3c2f1011d110
Route
ORAL
Published
Effective Date 2011-12-30
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Vitamin A (4000 [iU]) Ascorbic Acid (120 mg) Cholecalciferol (400 [iU]) .alpha.-tocopherol (22 [iU]) Thiamine Ion (1.84 mg) Riboflavin (3 mg) Niacin (20 mg) Pyridoxine (10 mg) Folic Acid (1 mg) Cyanocobalamin (12 ug) Calcium (200 mg) Ferrous Cation (27 mg) Zinc (25 mg) Copper (2 mg)
Inactive Ingredients
Microcrystalline Cellulose Croscarmellose Sodium Polyvinyl Alcohol, Unspecified Stearic Acid Titanium Dioxide Polyethylene Glycol, Unspecified Talc Magnesium Stearate Silicon Dioxide Caramel Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: M170 Shape: rectangle Color: brown Size: 19 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-10-01

Description

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.

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.

How Supplied

NDC: 63629-1140-1: 100 Tablets in a BOTTLE


Medication Information

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.

How Supplied

NDC: 63629-1140-1: 100 Tablets in a BOTTLE

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.

Section 42229-5

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.

Section 51945-4

M-Natal Plus Oral Tablet 27-1 MG#100

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.

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.


Structured Label Content

Section 42229-5 (42229-5)

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.

Section 51945-4 (51945-4)

M-Natal Plus Oral Tablet 27-1 MG#100

Caution (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.

Warning: (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.

Description (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.

How Supplied (HOW SUPPLIED)

NDC: 63629-1140-1: 100 Tablets in a BOTTLE

Dosage and Administration (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.


Advanced Ingredient Data


Raw Label Data

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