TANDEM PLUS: Package Insert and Label Information

TANDEM PLUS- sodium ascorbate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, ferrous fumarate, iron polymaltose, zinc sulfate monohydrate, cupric sulfate and manganese sulfate capsule
U.S. Pharmaceutical Corporation

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.

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

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.

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.

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.

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

Tandemnw
(click image for full-size original)

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 Item Code (Source) NDC:52747-902
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 187 mg
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 10.3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 6 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 30 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 20 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 10 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 53 mg
IRON POLYMALTOSE (FERRIC CATION) FERRIC CATION 53 mg
ZINC SULFATE MONOHYDRATE (ZINC CATION) ZINC CATION 18.2 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 0.8 mg
MANGANESE SULFATE (MANGANOUS CATION) MANGANOUS CATION 1.3 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
SILICON DIOXIDE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape CAPSULE (Oblong) Size 22mm
Flavor Imprint Code TandemPlus;US
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52747-902-60 90 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 04/01/2006
Labeler — U.S. Pharmaceutical Corporation (079467662)

Revised: 06/2022 U.S. Pharmaceutical Corporation

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