Pheniramine Maleate Tablets IP – Manufacturer & Exporter India

1. Product Introduction

Pheniramine maleate is a first-generation H1 antihistamine of the alkylamine class. It is used for symptomatic relief of certain allergic conditions, including allergic rhinitis and urticaria, subject to local approved indications. It can cause significant drowsiness and anticholinergic effects.

The supplied product composition identifies an uncoated tablet containing Pheniramine Maleate IP 25 mg. Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied marketing material; current certification and manufacturing details should be checked against official documents.

2. Product Specifications

3. Manufacturing Technology

Manufacturing an immediate-release antihistamine tablet requires validated blending, compression, content uniformity and disintegration controls. Appropriate moisture and light protection should be selected based on stability studies and the approved formulation.

The supplied product is described as uncoated; sugar coating, film coating, special light-shielded processing and particular packaging materials must not be claimed for this item without product-specific records.

4. Quality Assurance

Applicable product specifications may address identity, assay, uniformity of dosage units, disintegration or dissolution where required, impurities and stability. Acceptance criteria must match the current approved IP or validated product specification.

Claims such as 75% release within 45 minutes, a fixed 90–110% assay range or 36-month shelf life should be used only when supported by the relevant specification and stability documentation.

5. Therapeutic Information

Pheniramine blocks histamine H1 receptors, helping relieve symptoms such as sneezing, itching, runny nose and urticaria in approved settings. As a first-generation antihistamine it may cross into the central nervous system and cause sedation.

It is not a substitute for emergency treatment of anaphylaxis or severe airway swelling. Eczema, motion sickness and angioedema claims should be checked against the locally approved indication; severe swelling or breathing difficulty requires urgent medical attention.

6. Export and Regulatory Support

For pharmaceutical distribution and contract-manufacturing enquiries, confirm approved product strength, country-specific registration, labeling, packaging, minimum order quantity, batch documents and shipping requirements. CTD/ACTD dossiers, FSC, COPP, COA, WHO-GMP status and Star Export House status should be described as available only after documentary verification.

7. Frequently Asked Questions

What strength is specified? The supplied composition confirms Pheniramine Maleate IP 25 mg in an uncoated tablet. A 50 mg strength is mentioned elsewhere in the draft but is not confirmed by the composition.

Does it cause drowsiness? Yes. Sedation and impaired alertness are important risks; avoid driving or operating machinery until effects are known.

Is this the same as Avil? Avil is a separate branded medicine. A matching active ingredient alone does not establish therapeutic equivalence, identical formulation or interchangeability.

Can it treat a severe allergic reaction? It must not replace emergency treatment for anaphylaxis or breathing difficulty.

8. Dosage and Administration

Use only as directed in the approved local prescribing information and by a qualified healthcare professional. Dose and frequency depend on the patient, indication, age and product authorization. Do not apply the draft adult or child dosing schedules without checking the approved label; this 25 mg product should not be assumed appropriate for children.

9. Side Effects and Precautions

Possible effects include drowsiness, dizziness, dry mouth, blurred vision, constipation and urinary retention. Caution is required in people with narrow-angle glaucoma, urinary outflow obstruction, certain respiratory conditions and in older adults. Alcohol, sedatives and other medicines with anticholinergic effects may increase adverse effects.

Pregnancy, breastfeeding, pediatric use and drug interactions require clinician assessment. Seek urgent medical help for breathing difficulty, facial or throat swelling, severe confusion or serious allergic symptoms.

10. Storage Instructions

Store according to the approved label, protected from conditions that may affect product stability, and keep out of reach of children. The proposed below-30°C condition, light-protection requirement and shelf life must be checked against the final pack label and stability data.