TANDEM PLUS- sodium ascorbate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, d-calcium pantothenate, ferrous fumarate, polysaccharide iron complex, zinc sulfate, copper sulfate, manganese sulfate capsule

TANDEM PLUS by

Drug Labeling and Warnings

TANDEM PLUS 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*	% Daily Value for Pregnant or Lactating Women
Vitamin C (as Sodium Ascorbate)	187 mg	208%	156%
Vitamin B1 (as Thiamine Hydrochloride)	10.3 mg	858%	736%
Vitamin B2 (Riboflavin)	6 mg	462%	375%
Vitamin B3 (as Niacinamide)	30 mg	188%	167%
Vitamin B6 (as Pyridoxine HCL)	5 mg	294%	250%
Folic Acid	1 mg	250%	167%
Vitamin B12 (Cyanocobalamin)	20 mcg	833%	714%
Pantothenic Acid	10 mg	200%	143%
(as D-Calcium Pantothenate)
Iron	106 mg	589%	393%
(53 mg from Ferrous Fumarate; 53 mg from Polysaccharide Iron; Complex)    
Zinc (as Zinc Sulfate)	18.2 mg	165%	140%
Copper (as Copper Sulfate)	0.8 mg	89%	62%
Manganese (as Manganese Sulfate)	1.3 mg	57%	50%
* % Daily Values are based on a 2,000 calorie intake of adults and children 12 years and older.

Other Ingredients: Magnesium Stearate, Silicon Dioxide, Gelatin, Titanium Dioxide and FDA/E172 Red Iron Oxide

Tandem® Plus

IRON / FOLIC ACID / VITAMIN SUPPLEMENT CAPSULES

INDICATIONS: Tandem® Plus is an Rx dietary supplement indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. It is also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, as well as cases of metabolic stress, and in convalescence.

Ferrous Fumarate and Polysaccharide Iron Complex: All Tandem® products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). "An increase in tolerability is observed with the (patented formulation) and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient's blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism".

Clinical Studies: Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias: PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July-September 1982).

Folic Acid: Folic Acid is one of the important hematopoietic agents necessary for proper regeneration of the blood-forming elements and their function. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.

WARNINGS

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

PRECAUTIONS

PRECAUTIONS: Folic acid alone in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

DOSAGE & ADMINISTRATION

OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Keep this product and all drugs out of reach of children.

CONTRAINDICATIONS: Tandem® Plus is contraindicated in patients with a known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. It is also contraindicated in patients suffering from pernicious anemia as folic acid may obscure its signs and symptoms.

DOSAGE AND ADMINISTRATION: 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. Consult package insert for full prescription information.

SAFE HANDLING WARNING

HOW SUPPLIED: Tandem® Plus are pink opaque capsules radially printed in blue with "Tandem Plus" on the cap and 2 parallel lines of repeated "US" Logo on the body. Packed in child-resistant caps and light resistant bottles of 90 capsules (52747-0902-60). 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.

HEALTH CLAIM

CAUTION: Rx only.

Consult package literature for full prescription information. 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. Marketed by US Pharmaceutical Corporation. Store at room temperature 15° to 30°C (59° to 86°F) and dry place. Manufactured in a FDA registered facility in the USA.

Rev. 05/2022

Patent Numbers: U.S. Patent No: 11/243,043 Pending, Mexico MX/a/2008/004461; Singapore: 200802623-9 and other countries.

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.

Packaging

INGREDIENTS AND APPEARANCE

TANDEM PLUS 
sodium ascorbate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, d-calcium pantothenate, ferrous fumarate, polysaccharide iron complex, zinc sulfate, copper sulfate, manganese sulfate capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:52747-902
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	187 mg
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	10.3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	6 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	30 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	20 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	10 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	53 mg
IRON POLYMALTOSE (UNII: UM5219H89V) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	53 mg
ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.2 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	0.8 mg
MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANOUS CATION - UNII:H6EP7W5457)	MANGANOUS CATION	1.3 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:52747-902-60	90 in 1 BOTTLE, PLASTIC

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)	22 mm
scoring	1
imprint

Labeler - U.S. Pharmaceutical Corporation (079467662)