Ferrous Sulfate
FDA Label NDC 68210-1520

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product Ferrous Sulfate (NDC 68210-1520). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each caplet), otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, direction, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Active Ingredients (In Each Caplet)

Dried Ferrous Sulfate 325 mg

Otc - When Using

Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within tow hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing products may occasionally cause constipation or diarrhea.

Otc - Pregnancy Or Breast Feeding

If are pregnant or nursing a baby, seek the advise of a health professional before using this products.

Otc - Keep Out Of Reach Of 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.

Direction

  • *adults and children 12 years and over : take 1 tablet daily or as directed by a doctor
  • *Children under 12 years : consult a physician..

Other Information

  • *Store at room temperature

Inactive Ingredients

Starch USP, Calcium Carbonate USP, Guar Gum , Magnesium Stearate USP, Talc USP, Colloidal Silicon Dioxide USP, , Carnuba Wax

Principal Display Panel - 65 Mg Tablet Carton

Ferrous
Sulfate

NDC # 68210-1520-0

Iron Supplement
Therapy

  • #1 doctor recommended
    iron supplement
  • Easy to swallow
  • 65 mg of elemental iron per
    tablet – 360% of daily value
  • TAMPER EVIDENT –
    SEE SIDE PANEL

    100
    TABLETS

    Principal Display Panel (65 mg Tablet Carton)

    Principal Display Panel (65 mg Tablet Carton)

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