Label: 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
- NHRIC Code(s): 52747-902-60
- Packager: U.S. Pharmaceutical Corporation
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated June 6, 2022
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STATEMENT OF IDENTITY
Supplement Facts Serving Size: 1 Capsule Amount Per Serving %DV* % Daily Value for
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
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
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.
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.
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.
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.
INGREDIENTS AND APPEARANCE
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)