FERROUS SULFATE by LLC Federal Solutions / Silarx Pharmaceuticals, Inc
FERROUS SULFATE by
Drug Labeling and Warnings
FERROUS SULFATE by is a Otc medication manufactured, distributed, or labeled by LLC Federal Solutions, Silarx Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
FERROUS SULFATE- ferrous sulfate elixir
LLC Federal Solutions
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
----------
Active ingredient (in each 5 mL) (one teaspoonful)
Ferrous Sulfate 220 mg (equivalent to 44 mg of elemental Iron)
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.
Warning:
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.
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.
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
| FERROUS SULFATE
ferrous sulfate elixir |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
| Labeler - LLC Federal Solutions (965036895) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Silarx Pharmaceuticals, Inc | 161630033 | manufacture(24451-002) | |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.