Xylometazoline Hydrochloride Nasal Solution
Xylometazoline Hydrochloride USP And Benzalkonium Chloride Solution USP0.05% W/V
Therapeutic Class: Antihistamines
Dosage Forms: Liquids
Brand Name: Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v™
How it works?
Uses of Xylometazoline Hydrochloride Nasal Solution
What are the uses of Xylometazoline Hydrochloride Nasal Solution
- Relief from nasal congestion Helps clear a blocked nose caused by the common cold, making breathing easier.
- Allergic rhinitis support Provides relief in hay fever and other allergic conditions by reducing swelling in nasal passages.
- Perennial rhinitis management Useful for year‑round nasal congestion linked to chronic allergies.
- Sinusitis relief Reduces nasal blockage and pressure in the sinuses, easing discomfort.
Precautions of Xylometazoline Hydrochloride Nasal Solution
Patients are advised not to take decongestants for more than five consecutive days. Prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.
Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Use with caution in occlusive vascular disease.
If any of the following occur, Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v should be stopped
- Hallucinations
- Restlessness
- Sleep disturbances
Keep away from eyes. Keep medicines out of the sight and reach of children. Do not use Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v in children under 6 years old.
Information concerning excipients
Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v contains benzalkonium chloride. This may cause irritation of the nasal mucosa.
Dosages administration of Xylometazoline Hydrochloride Nasal Solution
Dosage
Adults and elderly: Not applicable.
Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v is contraindicated in children under 6 years of age.
Children between 6 and 12 years under adult supervision (all indications): 1 or 2 drops, in each nostril up to 2 times a day.
Do not use for more than 5 days without a doctor’s advice.
Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.
Not more than 2 doses should be given in any 24 hours
Direction for use:
Nasal use
Do not exceed the stated dose
Keep out of the reach and sight of children.
Side effects of Xylometazoline Hydrochloride Nasal Solution
The adverse effects listed below are classified by system organ class and frequency according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/10), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Immune System Disorders
Very rare: Hypersensitivity reaction (angioedema, rash, pruritus)
Nervous System Disorders
Common: Headache
Unknown: Irritability, Anxiety, Restlessness, Excitability, Insomnia, Hallucinations and Paranoid Delusions – particularly with prolonged and/or excessive use
Eye Disorders
Very rare: Transient visual impairment
Cardiac Disorders
Very rare: Heart rate irregular, Heart rate increased – particularly with prolonged and/or excessive use
Unknown: Other cardiac dysrhythmias and hypertension- particularly with prolonged and/or excessive use
Respiratory, thoracic and mediastinal disorders
Common: Nasal Dryness, Nasal Discomfort
Uncommon: Epistaxis
Gastrointestinal disorders
Common: Nausea
General disorders and administration site
Common: Application site burning
Unknown:
• Tolerance with diminished effect – especially with prolonged and/or heavy use
• Rebound congestion (rhinitis medicamentosa) – especially with prolonged and/or heavy use
• Irritation & dryness
Storage instruction of Xylometazoline Hydrochloride Nasal Solution
Do not store above 30°C. Protected from light. Keep the medicine out of reach of children.
Packing details of Xylometazoline Hydrochloride Nasal Solution
Xylometazoline Hydrochloride Nasal Solution USP 0.05% w/v comes in a 10 ml white HDPE bottle with a neck spray, packed in a unit carton with a pack insert.
interested? let’s talk.
Contact us directly to receive full information on the product, the formulation, the science behind it, stability data, and more. Our Business Development Manager is a click away.
Top GMP Certified Xylometazoline Hydrochloride Nasal Solution Manufacturer
Conical Pharmaceuticals, headquartered in Ahmedabad, India, is a GMP‑certified manufacturer & exporter manufacturer of Xylometazoline Hydrochloride Nasal Solution, delivering premium pharmaceutical and nutraceutical solutions worldwide.
Conical Pharmaceuticals is planning to Distribution is planned across Central America (Belize, Honduras, Nicaragua, Panama) and Central Africa (Cameroon, Chad, DRC, Equatorial Guinea, Gabon, Republic of the Congo), with further expansion into the Philippines, Saudi Arabia, the Netherlands, and Indonesia. As a leading third‑party contract pharmaceutical manufacturer, Conical Pharmaceuticals guarantees reliable supply and smooth market entry for partners worldwide.
Importers and distributors benefit from complete regulatory dossier support, including GMP Certification, Certificate of Analysis (COA), Free Sale Certificate, and COPP tailored to country‑specific requirements. With advanced R&D expertise, Conical Pharmaceuticals delivers effective formulations and consistent quality across international markets.
As a trusted bulk supplier and CDMO partner of Xylometazoline Hydrochloride Nasal Solution, the company supports private label and third‑party collaborations, empowering partners to expand their market presence with high‑quality hospital and supportive care therapies worldwide. Bulk supply is available to international importers, large‑scale distributors, pharmacy chains, hospital supply networks, and formulation innovators, ensuring broad accessibility and trusted partnerships across the healthcare ecosystem.
CUSTOM PACKAGING
Options available in size and style to meet your exact specifications and branding needs
SAMPLES AVAILABLE
Test before committing to bulk orders with complimentary samples for quality verification
LEAD TIME
45–60 days for timely delivery, ensuring reliable supply chain management
SHELF LIFE
Shelf Life: 24 months.
Frequently Asked Questions
Questions are useful tools, they open lines of communication; give us information; improve interactions, facilitate analysis, and many more.
-
Conical Pharmaceuticals, a WHO‑GMP certified pharmaceutical manufacturer in India, produces and exports Xylometazoline Hydrochloride Nasal Solution.
-
The product is WHO‑GMP compliant and supported with COA, COPP, and Free Sale Certificates for international markets.
-
It belongs to the nasal decongestant class, widely used in ENT and respiratory care.
-
Available in sterile nasal drop bottles and spray formats, with private label customization.
-
It provides relief from nasal congestion caused by the common cold, allergic rhinitis (hay fever), perennial rhinitis, and sinusitis.
-
Usually 1–2 drops or sprays in each nostril, up to 2–3 times daily, as directed by a physician.