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  5. Label Information: Ferrous Sulfate

FDA Label for Ferrous Sulfate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML) (ONE TEASPOONFUL)
    2. PURPOSE
    3. USES
    4. ADVERSE REACTIONS:
    5. DO NOT USE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
    10. TREATMENT OF OVERDOSE:
    11. DIRECTIONS
    12. INACTIVE INGREDIENTS
    13. OTHER INFORMATION

Ferrous Sulfate Product Label

The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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

* Please review the disclaimer below.