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FERROUS SULFATE by LLC Federal Solutions

Medically reviewed on August 21, 2017

Dosage form: elixir
Ingredients: FERROUS SULFATE 220mg in 5mL
Labeler: LLC Federal Solutions
NDC Code: 24451-002

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.

Supplemental Facts

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

Purpose
Iron Supplement

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.

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

FERROUS SULFATE 
ferrous sulfate elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24451-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (FERROUS CATION) FERROUS CATION220 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SUCROSE 
ALCOHOL 
SORBITOL 
PROPYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
SODIUM BENZOATE 
ASCORBIC ACID 
FD&C YELLOW NO. 6 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (LEMON FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:24451-002-055 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/12/2013
Labeler - LLC Federal Solutions (965036895)
Establishment
NameAddressID/FEIOperations
Silarx Pharmaceuticals, Inc161630033manufacture(24451-002)

 
LLC Federal Solutions

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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