IRON CHEWS- iron pentacarbonyl tablet, chewable

Iron Chews by

Drug Labeling and Warnings

Iron Chews by is a Other medication manufactured, distributed, or labeled by H2-Pharma, LLC, Nexgen Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

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

SAFE HANDLING WARNING

Keep out of reach of children.

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

STATEMENT OF IDENTITY

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.

HEALTH CLAIM

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

INGREDIENTS AND APPEARANCE

IRON CHEWS 
iron pentacarbonyl tablet, chewable

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:61269-910
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	15 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:61269-910-60	60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		10/31/2016

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	10 mm
flavor

Labeler - H2-Pharma, LLC (028473634)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		048488621	MANUFACTURE