nestabs

nestabs
SPL v8
SPL
SPL Set ID 61945c85-3c9a-4b57-a8e1-79dd0469a042
Route
oral
Published
Effective Date 2011-02-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.alpha.-tocopherol, d- (30 [iU]) riboflavin (3 mg) folic acid (1 mg) niacinamide (20 mg) cyanocobalamin (10 ug) iodide ion (100 ug) zinc cation (10 mg) ascorbic acid (120 mg) cholecalciferol (450 [iU]) pyridoxine (50 mg) calcium cation (155 mg) ferrous cation (45 mg) choline (32 mg)
Inactive Ingredients
titanium dioxide talc aluminum oxide carnauba wax fd&c red no. 40 saccharin cellulose, microcrystalline polyvinyl alcohol, unspecified magnesium stearate povidone

Identifiers & Packaging

Pill Appearance
Imprint: WC;001 Shape: oval Color: pink Size: 18 mm Score: 1
Marketing Status
unapproved drug other active Since 2011-02-01

Description

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 case of accidental overdose, call a doctor or poison control center immediately.


Medication Information

Recent Major Changes


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 case of accidental overdose, call a doctor or poison control center immediately.



Warnings and Precautions

Warnings:  Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

Indications and Usage

Indications and Usage:  Nestabs is indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.  Nestabs is also beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration

Dosage and Administration:  One tablet daily or as directed by a physician.

Contraindications

Contraindications:  This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description

Description: Nestabs tablets for oral administration is a light pink capsule shaped film coated tablet with a pleasant sweet flavor with WC001 imprinted on one side of the tablet.

Section 42232-9

  Precautions:  Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.  This product contains formate, which if consumed above the recommended level, could cause visual impairment and other health effects.  Do not take more than the recommended amount.  If you are pregnant, nursing, or taking any medications consult your doctor before use.  Discontinue use and consult your doctor if any adverse reactions occur.  Not intended for use by persons under the age of 18.

Section 51945-4


Structured Label Content

Recent Major Changes (34066-1)


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 case of accidental overdose, call a doctor or poison control center immediately.



Warnings and Precautions (34071-1)

Warnings:  Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

Indications and Usage (34067-9)

Indications and Usage:  Nestabs is indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.  Nestabs is also beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration (34068-7)

Dosage and Administration:  One tablet daily or as directed by a physician.

Contraindications (34070-3)

Contraindications:  This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description (34089-3)

Description: Nestabs tablets for oral administration is a light pink capsule shaped film coated tablet with a pleasant sweet flavor with WC001 imprinted on one side of the tablet.

Section 42232-9 (42232-9)

  Precautions:  Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.  This product contains formate, which if consumed above the recommended level, could cause visual impairment and other health effects.  Do not take more than the recommended amount.  If you are pregnant, nursing, or taking any medications consult your doctor before use.  Discontinue use and consult your doctor if any adverse reactions occur.  Not intended for use by persons under the age of 18.

Section 51945-4 (51945-4)


Advanced Ingredient Data


Raw Label Data

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