FERROUS SULFATE

LLC Federal Solutions

FULL PRESCRIBING INFORMATION

Supplemental Facts

Active ingredient

Active ingredient (in each 5 mL) (one teaspoonful)
Ferrous Sulfate 220 mg (equivalent to 44 mg of elemental Iron)

Purpose

Purpose
Iron Supplement

Uses

Uses
Iron supplements are used to treat or prevent low blood levels of iron, such as for anemia or during pregnancy

Warnings
Iron containing products should only be taken for very specific reasons and only under the advice and supervision of a doctor. Consult your doctor, for guidance for iron supplementation.

Do not exceed recommended dosage.

Do NOT use if

• you are allergic to any ingredient in Ferrous Sulfate Elixir
• you have high levels of iron in your blood

Ask a doctor or pharmacist before use if

• pregnant, planning to become pregnant, or are breast-feeding
• you are taking any prescription or over-the-counter medicines

Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron containing medications may occasionally cause constipation or diarrhea, and may cause temporary staining of the teeth. Mixing Ferrous Sulfate Elixir with water or fruit juice may help to decrease the effects.

Do not take Ferrous Sulfate Elixir within 1 hour before or 2 hours after antacids, eggs, milk, milk byproducts, coffee, or tea.

Keep out of reach of children.

Directions
Do not exceed recommended dosage. Do not mix with milk, milk byproducts, or wine-based vehicles.
Adults                                             1 teaspoonful daily or as directed by a doctor
Children under 12 years               Consult a doctor

Other ingredients
purified water, sucrose, alcohol (5%), sorbitol solution, propylene glycol, citric acid, lemon flavor, sodium benzoate, ascorbic acid, FD&C yellow no. 6, saccharin sodium.

Other information

• Store in tight, light-resistant container at room temperature

Manufactured by: Silarx Pharmaceuticals, Inc.
                                    19 West Street
                                    Spring Valley, NY 10977
Distributed by:         LLC Federal Solutions
                                    14 NE 1st Ave.
                                    Miami, FL 33132
Rev 108-00 07/2013

———PRINCIPAL DISPLAY PANEL———
NDC: 24451-002-05
FERROUS SULFATE
ELIXIR
220 mg / 5 mL
(EQUIVALENT TO 44 mg IRON)
DELIVERS 5 mL
LEMON FLAVOR
ALCOHOL 5%
Exp: 00/00/00   Lot # 00000

Mfg By: Silarx Pharmaceuticals, Inc.
Spring Valley, NY 10977 USA
Dist. By: LLC Federal Solutions
Miami, FL 33132