Levocetirizine dihydrochloride 5 mg is the active ingredient in a widely prescribed antihistamine tablet identified for U.S. markets by the FDA approved label and the NDC 50228136. This standardized profile ensures consistent dosing, quality, and regulatory compliance for patients managing allergic rhinitis or chronic idiopathic urticaria.
Below is a concise specification and policy overview for this specific NDC, designed for quick scanning and accurate reference by clinicians, pharmacists, and patients.
| Field | Details for NDC 50228136 | Regulatory Reference | Key Notes |
|---|---|---|---|
| Product Name | Levocetirizine Dihydrochloride 5 mg Tablets | FDA Approved Label | Antihistamine for allergic rhinitis and urticaria |
| NDC | 50228136-001-01 | National Drug Code | Unique identifier for this strength and package |
| Active Ingredient | Levocetirizine Dihydrochloride | USP Monograph | R-enantiomer of cetirizine with potent H1 receptor antagonism |
| Typical Dosage | 5 mg once daily | Label Prescribing Information | Adjustments for renal impairment and elderly patients |
| Controlled Substance | No | FDA Schedule Classification | Not a controlled substance under CSA |
Labeled Indications and Clinical Use
Allergic Rhinitis Management
The FDA label for levocetirizine dihydrochloride 5 mg supports use in persistent allergic rhinitis, helping to relieve sneezing, rhinorrhea, and nasal itching. This aligns with the labeled indication on the official FDA approved label tied to NDC 50228136.
Chronic Idiopathic Urticaria Control
Patients with chronic idiopathic urticaria may experience reduced wheal formation and pruritus when following the labeled dosing schedule. The FDA label provides specific guidance on safety and efficacy for this condition based on clinical trial data tied to this NDC.
Dosing, Administration, and Safety Considerations
Standard Adult Dosing
For most adults, the recommended dose is one 5 mg tablet taken orally once daily, with or without food, as specified on the FDA label. Renal and hepatic function should be assessed to adjust dosing appropriately.
Pediatric and Geriatric Adjustments
Pediatric patients and older adults may require dose modifications due to increased sensitivity or renal function decline. The label outlines these adjustments to minimize risks such as somnolence or dry mouth while maintaining symptom control.
Adverse Effects and Monitoring Recommendations
Common and Notable Reactions
Somnolence, fatigue, headache, and dry mouth are frequently reported. The FDA label highlights rare but serious reactions, including cardiac events in susceptible individuals when combined with certain medications.
Drug Interaction Profile
Coadministration with central nervous system depressants may potentiate sedative effects. Review of the label is essential when patients use medications that prolong the QT interval or affect hepatic metabolism pathways.
Practical Guidance and Key Takeaways
- Always confirm the NDC 50228136 on the packaging to ensure the correct strength and formulation.
- Use the medication at the same time each day to maintain steady symptom control.
- Store tablets at room temperature, away from moisture and direct light.
- Report any severe drowsiness, mood changes, or irregular heartbeat to your clinician promptly.
- Discuss potential interactions with your pharmacist, especially when starting new prescription or over-the-counter products.
FAQ
Reader questions
How quickly does levocetirizine dihydrochloride 5 mg work for allergies?
Many patients notice reduced allergy symptoms within one hour, with peak effects around 4 to 6 hours after taking the tablet labeled under NDC 50228136.
Can this medication be taken long term for chronic urticaria?
Yes, the FDA label supports long-term use for chronic idiopathic urticaria, provided patients are monitored for tolerance and potential changes in renal or hepatic function over time.
Is it safe to combine levocetirizine with other allergy medications?
Combining with other antihistamines or sedatives can increase drowsiness and other side effects; consult a healthcare provider before making changes to concurrent therapies.
What should I do if I miss a dose of this antihistamine?
Take the missed dose as soon as you remember unless it is near the time for the next scheduled dose; do not double up to compensate for a missed tablet.