Ferrous Gluconate Tablets, USP 324 mg

General Statements: All Other Content

69367-165-04

FDA Statement of Identity

Iron Supplement

Formula re: Contains

Description: Each tablet contains 324 mg a ferrous gluconate, equivalent to 38 mg of elemental iron, providing 211% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

Formula re: Type

Description: Each tablet contains 324 mg a ferrous gluconate, equivalent to 38 mg of elemental iron, providing 211% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

Suggested/Recommended/Usage/Directions

Directions for Use: Do not crush or chew tablets. Adult Serving Size: 1 tablet three to four times daily. Children: Consult a physician.

Precautions re: Children

Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center Immediately.

Precautions re: Pregnant or Nursing or Prescription Medications

Warnings: Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicine and vitamins with iron be packaged in child-resistant closures.

Precautions re: All Other

Parents should always property resecure safety closures.

Storage

Storage: Store at 20 degrees – 25 degrees C (68 degrees – 77 degrees F) [see USP Controlled Room Temperature]