TANDEM PLUS

Manufacturer
U.S. Pharmaceutical Corporation
Effective date
2022-06-06
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:28

Label at a glance#

ProductTANDEM PLUS
Active ingredientSODIUM ASCORBATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, FERROUS FUMARATE, IRON POLYMALTOSE, ZINC SULFATE MONOHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE
Label structure7 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

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 SECTION

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

PRECAUTIONS SECTION

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 SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TandemnwTandemnw

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
FERRIC CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
MANGANESE CATION (2+) Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
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ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52747-902-60TANDEM PLUS90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52747-902TANDEM 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 [U.S. PHARMACEUTICAL CORPORATION]11 package rows20220610_3736be6a-8fd8-4ee7-a954-e3ee4afc89ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52747-902-60EA - Each52747-9023dc17a7b-7648-4aa3-8c0a-1a247ddfc78112012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52747-90252747-902-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.