Iron Chews

IRON CHEWS- iron pentacarbonyl tablet, chewable
Midlothian Laboratories

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION

A round purple-colored pediatric iron chewable tablet that contains:

Iron (as Carbonyl Iron) ………………………………….15 mg

Inactive Ingredients:

Sorbitol, Microcrystalline Cellulose, Artificial Grape Flavor,

Silica, Magnesium Stearate, FD&C Blue #2 Lake, FD&C Red #40 Lake

INDICATIONS AND USAGE

As an iron supplement for patients as prescribed by their physician.

CONTRAINDICATIONS

Allergies or hypersensitivity to any of the ingredients.

WARNINGS

ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A

LEADING CAUSE OF FATAL POISONING IN CHILDREN UNDER SIX YEARS. KEEP

THIS PRODUCT OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, CALL A

DOCTOR OR POISON CONTROL CENTER IMMEDIATELY.

PRECAUTIONS

Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a health professional. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other.

Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals.

Iron-containing medication may occasionally cause constipation or diarrhea. If you are pregnant or nursing a baby, seek the advice of a health professional prior to taking this product.

DOSAGE AND ADMINISTRATION

As an Iron Supplement, one chewable tablet daily, or as directed by a health professional.

HOW SUPPLIED

A round purple-colored pediatric iron chewable tablet in bottles of sixty tablets.

NDC 68308-910-60

Protect from light, heat and moisture. Store at 59° — 86°F (15° — 30°C)

Manufactured for:

Midlothian Laboratories, Inc.

Montgomery, AL 36116

Rev. 12/09

CONTAINER LABEL

IRON CHEWS PDP
(click image for full-size original)

Immediate Container Label

IRON CHEWS
mineral tablet tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68308-910
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON PENTACARBONYL (IRON) IRON PENTACARBONYL 15 mg
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 10mm
Flavor GRAPE (Artificial) Imprint Code NONE
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68308-910-60 60 TABLET, CHEWABLE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2009
Labeler — Midlothian Laboratories (142122824)

Revised: 11/2009 Midlothian Laboratories

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