Your browser does not support JavaScript! FERROUS SULFATE ELIXIR [RIJ PHARMACEUTICAL CORPORATION]
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RxNorm Names

FERROUS SULFATE elixir
[Rij Pharmaceutical Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

Active ingredient (in each 5 mL) (one teaspoonful)

Ferrous Sulfate 220 mg (44 mg of elemental Iron)

Purpose

Iron Supplement

Uses

a therapy for simple iron deficiency and iron deficiency anemia

Warnings

Adverse Reactions:

occasional gastrointestinal discomfort such as nausea dose related bowel effects (such as constipation or diarrhea), gastrointestinal effects may be minimized by the administration with or immediately after meals and bowel effects reduced by giving the minimum effective dosage.

Do not use

  • more than directed

The treatment of any anemic condition should be under the advice and supervision of a physician

Ask a doctor or pharmacist before use if you are

taking oral Tetracycline antibiotics. Oral iron products interfere with absorption of oral tetracycline antibiotics. These products should not be taken within two hours of each other.

When using this product

  • may occasionally cause constipation or diarrhea
  • may cause temporary staining of the teeth (this is less likely when diluted)

If pregnant or breast-feeding

ask a health professional before use.

Keep this and all drugs out of reach of children.

Contains iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Treatment of overdose:

quickly induce vomiting, then feed eggs and milk until gastric lavage can be done. Lavage with 1 percent Sodium Bicarbonate and administer an iron chelating agent (such as deferoxamine mesylate) BAL should not be used. Gastric lavage should not be performed after the first hour because the danger of perforation due to gastric necrosis. Measures to combat shock, dehydration, blood loss and respiratory failure may be necessary.

Directions

Mix with water or fruit juice to avoid temporary staining of the teeth, do not mix with milk or wine-based vehicles

Adults and children 12 years of age and over1 teaspoonful daily, or as directed by a physician
Children under 12 years of ageConsult a physician

Inactive ingredients

citric acid, FD & C yellow #6, flavor, sodium benzoate, sucrose and water.

Other information

Store in tight, light-resistant container at room temperature

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
FERROUS SULFATE 
ferrous sulfate elixir
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53807-177
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
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 6 
SODIUM BENZOATE 
SUCROSE 
WATER 
Product Characteristics
ColorORANGEScore    
ShapeSize
Flavor PEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-177-08236 mL in 1 BOTTLE
2NDC:53807-177-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER03/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)

Revised: 4/2013
 
Rij Pharmaceutical Corporation

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