Tandem
FDA Label NDC 52747-900

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Us Pharmaceutical Corporation for the product Tandem (NDC 52747-900). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding statement of identity, side effects:, dosage:, safe handling warning, warnings, health claim, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Statement Of Identity

 Supplement Facts
 Serving Size: 1 Capsule
 Amount Per Serving%DV*
 Iron106 mg589%
    (53 mg from Ferrous Fumarate)
    (53 mg from Polysaccharide Iron Complex)
 * Percent daily value based on 2,000 calorie diet

Other Ingredients: Microcrystalline Cellulose, Gelatin, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FDA/E172 Yellow Iron Oxide, FDA/172 Black Iron oxide and FDA/E172 Red Iron Oxide

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.

INDICATIONS: The treatment of iron deficiency anemia, which may occur due to an increased need for iron, a deficient intake of iron or an excessive loss of iron.

Side Effects:

Gastrointestinal disturbance (anorexia, nausea, diarrhea, constipation) occur occasionally but are usually mild and subside with continuation of therapy.

Dosage:

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. If you are pregnant or nursing a baby, seek the advice of a health professional before using the product.

HOW SUPPLIED: Tandem® are light brown opaque capsules printed radially in red with "Tandem" on the cap and 2 parallel lines of repeated "US" logo on the body. Available in box of 90 blister packed capsules (52747-0900-90). 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.

Safe Handling Warning

Do not purchase if any portion of product is opened. Store at room temperature 15° to 30°C (59° to 86°F) and dry place.

Warnings

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.

Health Claim

Ferrous Fumarate / Polysaccharide Iron Complex Supplement Capsules

Packaging

Capsule Outer Carton (52747)

Capsule Outer Carton (52747)

* Please review the disclaimer below.