IRON CHEWS- mineral tablet tablet, chewable 
Mayne Pharma Inc.

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.

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Iron Chews

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

Immediate Container Label

IRON CHEWS 
mineral tablet tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68308-910
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION15 mg
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize10mm
FlavorGRAPE (Artificial) Imprint Code NONE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68308-910-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/01/200912/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/200912/31/2016
Labeler - Mayne Pharma Inc. (867220261)

Revised: 12/2017
 
Mayne Pharma Inc.