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Iron Folic Acid Tablets – Ferrous Sulphate with Folic Acid

Iron Folic Acid Tablets

Composition (enteric-coated): Dried Ferrous Sulphate 335 mg (equivalent to elemental iron IP 100 mg) + Folic Acid IP 0.5 mg.

Composition (sugar-coated): Ferrous Sulphate IP 200 mg (equivalent to elemental iron IP 60 mg) + Folic Acid IP 0.5 mg.

Usage: Prevention or treatment of iron deficiency and folate deficiency when clinically indicated.

Category: Generic Drugs and Medicine

Therapeutic Category: Haematinic / Antianaemic

SKU: Iron Folic Acid Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Iron Folic Acid Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Iron & Folic Acid Tablets (IFA)

1. Product Introduction

Iron Folic Acid Tablets (IFA) combine a ferrous iron salt with folic acid (vitamin B9). Iron is needed for haemoglobin production, while folate supports normal red-blood-cell formation and fetal neural-tube development. The supplied products include an enteric-coated tablet delivering 100 mg elemental iron with 0.5 mg folic acid and a sugar-coated tablet delivering 60 mg elemental iron with 0.5 mg folic acid.

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

2. Product Specifications

VariantPer-tablet compositionDosage formAdditional listed ingredients
Iron with Folic Acid Tablets IP — 100 mg elemental ironDried Ferrous Sulphate 335 mg, equivalent to elemental iron IP 100 mg; Folic Acid IP 0.5 mg (500 mcg)Enteric-coatedIndigo Carmine; excipients (quantities not specified)
Iron with Folic Acid Tablets IP — 60 mg elemental ironFerrous Sulphate IP 200 mg, equivalent to elemental iron IP 60 mg; Folic Acid IP 0.5 mg (500 mcg)Sugar-coatedPonceau 4R (in-house); excipients q.s.

Therapeutic class: Haematinic / Antianaemic / Iron and folate supplement. Standard: IP, as identified in the supplied compositions. Note: 400 mcg and 1.5 mg folic acid strengths, ferrous fumarate, shelf life and pack configurations were mentioned in background text but are not verified for these two variants.

3. Manufacturing Technology

Manufacturing considerations include accurate low-dose folic acid blending, consistent iron content, coating integrity, protection from humidity and appropriate packaging. The 100 mg variant is specified as enteric-coated and the 60 mg variant as sugar-coated; these dosage forms should not be described interchangeably. Particular granulation methods, antioxidant systems and dedicated equipment should be confirmed against the actual manufacturing record before publication.

4. Quality Assurance

Product-specific quality control may include identification, assay of elemental iron and folic acid, content uniformity, disintegration or dissolution as appropriate to coating type, impurities, microbiological controls where applicable, and stability testing. Exact acceptance criteria, expiry period and pharmacopoeial claims require an approved specification and certificate of analysis.

5. Pharmacology and Clinical Use

Iron replenishes iron stores and supports haemoglobin synthesis. Folic acid supports DNA synthesis and red-blood-cell development. Iron–folic acid supplements may be used to prevent or treat iron deficiency and folate deficiency, including in pregnancy where indicated. The prescribed elemental-iron dose should reflect haemoglobin, ferritin, age, pregnancy status and tolerance; not all anaemia is caused by iron deficiency.

Folic acid taken before conception and in early pregnancy helps lower the risk of neural-tube defects. The appropriate regimen and product should follow local antenatal guidance.

6. Export and Regulatory Support

For wholesale, tender and contract-manufacturing enquiries, request current product-specific documentation such as certificates of analysis, stability data, artwork, manufacturing licence and CTD/ACTD materials where available. Regulatory approvals, WHO procurement eligibility, certification and shipping terms must be verified for the product and destination market.

7. Frequently Asked Questions

Q: How much folic acid is in each confirmed variant?
A: Both contain 0.5 mg (500 mcg) per tablet.

Q: What is the difference between 335 mg dried ferrous sulphate and 100 mg elemental iron?
A: The salt weight includes the sulphate component; the label specifies the equivalent amount of elemental iron.

Q: Can I take iron tablets with milk?
A: Calcium-containing foods and supplements can reduce iron absorption. Ask your pharmacist how to space doses and other medicines.

Q: Are dark stools normal?
A: Iron can darken stools, but tarry stools with weakness, pain or bleeding symptoms need urgent assessment.

8. Dosage and Administration

Use only as prescribed or directed by an appropriate healthcare professional. Preventive and treatment doses vary; do not assume that a 60 mg or 100 mg elemental-iron tablet is interchangeable with another formulation. Swallow coated tablets whole unless the approved label says otherwise. Taking iron on an empty stomach can improve absorption but may worsen nausea; a clinician may recommend taking it with food. Separate from calcium, antacids, levothyroxine and certain antibiotics according to pharmacist guidance.

9. Side Effects and Precautions

  • Common effects: Nausea, abdominal discomfort, constipation, diarrhoea and dark stools.
  • Iron overload: Do not use for haemochromatosis or other iron-overload states unless specifically directed.
  • Interactions: Iron can interfere with absorption of certain antibiotics and thyroid medication; timing matters.
  • Folate: Folic acid may mask haematological signs of vitamin B12 deficiency while neurological injury progresses; evaluate suspected B12 deficiency.
  • Child safety: Accidental iron overdose can be fatal in children. Keep tablets securely out of reach and seek urgent emergency care after suspected overdose.

10. Storage Instructions

Keep in the original, tightly closed packaging in a dry place, protected from excess heat and moisture, following the approved label. A specific below-25°C storage limit and shelf life should be confirmed against the product stability data. Store securely away from children.