Promethazine Hydrochloride Tablets – Manufacturer & Exporter India

1. Product Introduction

Promethazine hydrochloride is a sedating first-generation H1 antihistamine of the phenothiazine family. Depending on the local approved indication, it is used for allergy symptoms, prevention of motion sickness and management of nausea and vomiting. The supplied formulations are sugar-coated tablets in BP 10 mg, BP 25 mg and IP 25 mg strengths. Healthy Life Pharma Pvt. Ltd. is named as manufacturer and Healthy Inc as exporter in the supplied product information.

Emergency warning: Promethazine is not a substitute for intramuscular epinephrine (adrenaline), the first-line treatment for anaphylaxis. Suspected anaphylaxis requires immediate emergency care.

2. Product Specifications

Therapeutic class: Antihistamine / Antiemetic / Sedating antihistamine. Packaging and shelf life: Confirm from approved artwork and stability data. Film-coated versions are not established by the supplied composition.

3. Manufacturing Technology

For promethazine hydrochloride, formulation development should consider content uniformity, coating integrity, light exposure, oxidative stability and suitable protective packaging. The submitted product specifies sugar-coated tablets; specific manufacturing equipment, coating recipes, specialized lighting, oxidation controls and commercial pack configurations require process and stability documentation before being claimed as implemented.

4. Quality Assurance

Relevant quality controls can include identification, assay, uniformity of dosage units, dissolution/disintegration where applicable, related substances, coating integrity and stability studies. Testing and acceptance limits must follow the current applicable pharmacopoeial monograph and the registered product specification. Batch COA and supporting records should be reviewed for procurement.

5. Mechanism and Therapeutic Uses

Promethazine blocks histamine H1 receptors and has central sedative and anticholinergic effects. Its licensed indications vary by market and product label.

• Allergic conditions: May relieve symptoms such as sneezing, itching and hives.
• Motion sickness: May be used to prevent travel-related nausea where approved.
• Nausea and vomiting: Used in selected clinical situations under professional advice.
• Sedation: Some products have approved short-term sedative indications, subject to age restrictions and local guidance.

Promethazine does not replace emergency treatment for severe allergic reactions or anaphylaxis.

6. Export and Regulatory Support

For B2B enquiries, request current manufacturing and product licenses, GMP evidence, approved labels, specifications, batch COA and stability information. CTD/ACTD dossiers, FSC, COPP, shipping terms and country-specific registrations are subject to availability and documentary verification. Exporter status and certifications must not be assumed from marketing text alone.

7. Frequently Asked Questions

Which tablet strengths are listed?

IP 25 mg and BP 10 mg / 25 mg, all sugar-coated tablets.

Will promethazine make me drowsy?

Yes. It can impair alertness; avoid driving and alcohol, and discuss other sedating medicines with a clinician.

Can promethazine treat anaphylaxis?

It must not delay or replace epinephrine (adrenaline) and emergency medical care for anaphylaxis.

Can it be given to young children?

Promethazine is contraindicated in children younger than 2 years due to potentially fatal respiratory depression. Additional pediatric age restrictions vary by jurisdiction and formulation; follow the local approved label.

8. Dosage and Administration

Dosing varies by indication, age, medical history and country-specific approved labeling. Use only as directed by a qualified healthcare professional. Swallow the sugar-coated tablet according to its label. Do not use adult dose schedules for children. Seek urgent care for severe allergic symptoms, breathing difficulty or persistent vomiting with dehydration.

9. Side Effects and Precautions

• Respiratory depression: Contraindicated under age 2; potentially life-threatening, particularly with other respiratory depressants.
• Sedation: Marked drowsiness, dizziness and impaired coordination; alcohol, opioids and other CNS depressants can increase risks.
• Anticholinergic effects: Dry mouth, constipation, blurred vision and urinary retention; caution with glaucoma and prostatic enlargement.
• Other cautions: Older adults may be more susceptible to confusion and falls; possible photosensitivity, paradoxical excitation and interactions with other medicines.
• Emergency: For swelling of the throat, wheezing, collapse or suspected anaphylaxis, obtain emergency care immediately; epinephrine is first-line.

10. Storage Instructions

Store in the original packaging according to the approved label, protected from light and unsuitable heat or moisture. Keep out of reach of children. The exact temperature range and shelf life must be verified against the registered pack information.

Important: Educational and B2B product information; not a substitute for approved prescribing information or professional medical advice. Company credentials and commercial specifications require verification.