Label: FERROUS SULFATE- ferrous sulfate elixir
- NDC Code(s): 53807-177-08, 53807-177-16
- Packager: Rij Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each 5 mL) (one teaspoonful)
Ferrous Sulfate 220 mg (44 mg of elemental Iron)Close
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)
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.
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 over 1 teaspoonful daily, or as directed by a physician Children under 12 years of age Consult a physician
- Inactive ingredients
citric acid, FD & C yellow #6, flavor, sodium benzoate, sucrose and water.Close
- Other information
- Store in tight, light-resistant container at room temperature
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ferrous sulfate elixir
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-177 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 220 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-177-08 236 mL in 1 BOTTLE 2 NDC:53807-177-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156)