Iron Chews: Package Insert and Label Information

IRON CHEWS- iron pentacarbonyl tablet, chewable
H2-Pharma, LLC

Directions

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

Keep out of reach of children.

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

Supplement Facts
Serving Size 1 Tablet Servings per container: 60
Amount Per Serving % Daily Value
Infants from birth to 12 months of age
% Daily Value
Children under 4 years of age
Iron (as Carbonyl Iron) 15 mg 100% 150%

Other Ingredients : Sorbitol, microcrystalline cellulose, artificial grape flavor, magnesium stearate, silica, FD&C Blue #2 Lake, and FD&C Red #40 Lake.

CAUTION

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.

WARNING

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.

H2 pharma
www.h2-pharma.com

Rev. 09/16

PRINCIPAL DISPLAY PANEL — 15 mg Tablet Bottle Label

Iron Chews

Pediatric
Chewables

IRON SUPPLEMENT

Each Tablet Contains: Iron (as carbonyl iron) …….15 mg

H2 pharma

61269-910-60 60 TABLETS

Principal Display Panel -- 15 mg Tablet Bottle Label
(click image for full-size original)
IRON CHEWS
iron pentacarbonyl tablet, chewable
Product Information
Product Type Item Code (Source) NDC:61269-910
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 15 mg
Inactive Ingredients
Ingredient Name Strength
SORBITOL
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 10mm
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61269-910-60 60 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 10/31/2016
Labeler — H2-Pharma, LLC (028473634)

Revised: 07/2022 H2-Pharma, LLC

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