FDA Label for Tandem Plus
View Indications, Usage & Precautions
Tandem Plus Product Label
The following document was submitted to the FDA by the labeler of this product Us Pharmaceutical Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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