TANDEM- ferrous fumarate, polysaccharide iron complex capsule

Tandem by

Drug Labeling and Warnings

Tandem by is a Other medication manufactured, distributed, or labeled by U.S. Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Serving Size: 1 Capsule
Amount Per Serving		%DV*
Iron	106 mg	589%
(53 mg from Ferrous Fumarate)
(53 mg from Polysaccharide Iron Complex)
* Percent daily value based on 2,000 calorie diet

Other Ingredients: Microcrystalline Cellulose, Gelatin, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FDA/E172 Yellow Iron Oxide, FDA/172 Black Iron oxide and FDA/E172 Red Iron Oxide

You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036.

INDICATIONS: The treatment of iron deficiency anemia, which may occur due to an increased need for iron, a deficient intake of iron or an excessive loss of iron.

SIDE EFFECTS:

Gastrointestinal disturbance (anorexia, nausea, diarrhea, constipation) occur occasionally but are usually mild and subside with continuation of therapy.

DOSAGE:

Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12. If you are pregnant or nursing a baby, seek the advice of a health professional before using the product.

HOW SUPPLIED: Tandem® are light brown opaque capsules printed radially in red with "Tandem" on the cap and 2 parallel lines of repeated "US" logo on the body. Available in box of 90 blister packed capsules (52747-0900-90). The listed product number is not a National Drug Code. Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

SAFE HANDLING WARNING

Do not purchase if any portion of product is opened. Store at room temperature 15° to 30°C (59° to 86°F) and dry place.

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

HEALTH CLAIM

Ferrous Fumarate / Polysaccharide Iron Complex Supplement Capsules

Packaging

INGREDIENTS AND APPEARANCE

TANDEM 
ferrous fumarate, polysaccharide iron complex capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:52747-900
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	53 mg
IRON POLYMALTOSE (UNII: UM5219H89V) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	53 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:52747-900-90	9 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/01/2006

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	19 mm
scoring	1
imprint

Labeler - U.S. Pharmaceutical Corporation (079467662)