What Montek-LC actually is
Montek-LC is a prescription-only tablet from Sun Pharmaceutical Industries containing montelukast 10 mg and levocetirizine 5 mg. It is taken once daily in the evening for allergic rhinitis, chronic urticaria and as add-on therapy in asthma. It is not a reliever inhaler, not an antibiotic, and not a cough syrup.
The part most sources leave out: since March 2020 the US FDA has required a boxed warning on every montelukast product for serious neuropsychiatric events, and instructs prescribers to reserve montelukast for allergic rhinitis only in patients who cannot tolerate or do not respond to other allergy medicines.[1][3] If allergic rhinitis is your only diagnosis, that restriction is the single most important thing to discuss with your doctor.
Composition: what is inside the tablet
Montek-LC is a fixed-dose combination (FDC). Each film-coated tablet carries two actives working on two different arms of the allergic response, plus the usual tablet excipients.
| Component | Role | Strength | What it does |
|---|---|---|---|
| Montelukast sodium | Active | Eq. to montelukast 10 mg | Selective cysteinyl leukotriene (CysLT1) receptor antagonist. Blocks LTD4-driven bronchoconstriction, mucus secretion and mucosal oedema.[1] |
| Levocetirizine dihydrochloride | Active | Eq. to levocetirizine 5 mg | Second-generation H1-antihistamine, the active R-enantiomer of cetirizine. Blocks histamine-driven sneezing, itch, rhinorrhoea and weals.[2] |
| Microcrystalline cellulose | Diluent / binder | q.s. | Provides bulk and compressibility. |
| Croscarmellose sodium | Superdisintegrant | q.s. | Breaks the tablet up in the stomach so the actives can dissolve. |
| Magnesium stearate | Lubricant | q.s. | Prevents sticking during compression. |
| Colloidal silicon dioxide | Glidant | q.s. | Improves powder flow. |
| Film-coating system (HPMC based) | Coating | q.s. | Moisture and light barrier; montelukast is light-sensitive. |
Scroll the table sideways on a phone. Excipients vary between brands and are listed on the individual pack insert.
Why two drugs in one tablet?
Allergy runs on at least two independent chemical pathways. Histamine causes the sneezing, itching and running nose. Cysteinyl leukotrienes cause the blocked nose and the airway tightening. Blocking only one leaves the other running. In a randomised trial in 147 children aged 6 to 14 with perennial allergic rhinitis, a montelukast plus levocetirizine combination reduced daytime nasal congestion (p = 0.0341) and rhinorrhoea (p = 0.0469) more than montelukast alone.[5] That is the clinical rationale for the FDC — and it is an argument for the combination over montelukast alone, not over an antihistamine alone.
What Montek-LC is used for
The four uses below are taken from the approved prescribing information for each active. Pick the tab that matches your situation — the detail differs meaningfully between them.
Seasonal and perennial allergic rhinitis
This is the commonest reason Montek-LC is prescribed in India: sneezing, blocked nose, watery discharge and itchy eyes from pollen, dust mite, mould or pet dander. Levocetirizine is approved for seasonal allergic rhinitis from 2 years of age and perennial allergic rhinitis from 6 months.[2] Montelukast is approved for both.[1]
The limitation that matters. The montelukast label carries an explicit Limitation of Use for allergic rhinitis: reserve it for patients who have an inadequate response or intolerance to alternative therapies, because the risk of neuropsychiatric events may not be justified for hay fever alone.[1][3] An antihistamine or an intranasal steroid is the first-line option. Montek-LC is a second-line choice for rhinitis, even though it is often written as a first prescription.
Asthma — maintenance only
Montelukast is approved for prophylaxis and chronic treatment of asthma.[1] It is an add-on controller, not a reliever. It will do nothing for an acute attack, and it does not replace an inhaled corticosteroid. GINA continues to position leukotriene receptor antagonists below inhaled corticosteroid-containing therapy for asthma control.[7]
If you have been given Montek-LC for asthma, you should still have a reliever inhaler, and you should know when to use it. Stopping your inhaler because a tablet feels easier is the most common and most dangerous mistake with this drug class.
Chronic urticaria and allergic itch
Levocetirizine is approved for chronic idiopathic urticaria — recurrent weals and itching, from 6 months of age upward.[2] In urticaria the antihistamine component is doing almost all of the work; montelukast is an adjunct with a much weaker evidence base for this indication.
Practical consequence: if hives are your only problem, ask your doctor whether a plain second-generation antihistamine would do the same job. It avoids the montelukast boxed warning entirely.[3]
Exercise-induced bronchoconstriction
Montelukast is approved for prevention of exercise-induced bronchoconstriction in patients 6 years and older. The label instruction is specific: a single 10 mg dose taken at least 2 hours before exercise.[1] Taking it at the gym door does not work — the drug needs 3 to 4 hours to reach peak plasma concentration.[1]
An additional dose must not be taken within 24 hours if you are already on daily montelukast for asthma or rhinitis.[1]
Dose, timing and who should not take it
| Group | Position on the adult 10 mg / 5 mg tablet | Basis |
|---|---|---|
| Adults and adolescents 12 years and over | One tablet once daily, in the evening. Swallow whole. | Levocetirizine 5 mg once daily in the evening; montelukast 10 mg once daily.[1][2] |
| Children 6 to 11 years | Not this strength. Levocetirizine must not exceed 2.5 mg daily in this age band. | Paediatric levocetirizine dose is 2.5 mg once daily in the evening, and the label states this dose should not be exceeded.[2] |
| Children under 6 years | Not this tablet. Age-appropriate paediatric formulations only, on prescription. | Strength and dosage form are unsuitable.[2] |
| Mild renal impairment (CrCl 50–80 mL/min) | Levocetirizine reduces to 2.5 mg daily — the fixed 5 mg combination cannot deliver that. | Renal dose adjustment table.[2] |
| Moderate impairment (CrCl 30–50 mL/min) | 2.5 mg every other day. | Renal dose adjustment table.[2] |
| Severe impairment (CrCl 10–30 mL/min) | 2.5 mg twice weekly. | Renal dose adjustment table.[2] |
| End-stage renal disease (CrCl under 10 mL/min) and haemodialysis patients | Contraindicated. Must not receive levocetirizine. | Explicit contraindication.[2] |
| Hepatic impairment | No montelukast dose adjustment for mild to moderate hepatic insufficiency. Severe impairment has not been studied. | Montelukast label.[1] |
CrCl = creatinine clearance. Fixed-dose combinations cannot be dose-adjusted — that is their main clinical limitation.
Contraindications
Check your own situation
Montek-LC suitability check
Three questions drawn from the approved label. This does not replace your prescriber — it tells you what to raise with them.
Select one answer in each of the three questions
The verdict and the governing label provision will appear here.
Governing provision: pendingSide effects: the real numbers
Common effects
The most talked-about side effect of Montek-LC is drowsiness, and it is routinely overstated online. In the controlled adult trials that supported approval of levocetirizine 5 mg, somnolence occurred in 6% of patients on 5 mg versus 2% on placebo — a real but modest excess of about four percentage points.[2] That is far below first-generation antihistamines, and it is the reason the tablet is dosed in the evening.
- Somnolence and fatigue — 6% versus 2% on placebo in adults.[2]
- Headache, dry mouth, nasopharyngitis and pharyngitis.[1][2]
- Abdominal discomfort, nausea, dyspepsia.[1]
- Mild rash.
The boxed warning — and what the newer evidence says
On 4 March 2020 the US FDA required a boxed warning, its most serious label warning, on all montelukast products.[3] The warning text reads that serious neuropsychiatric events have been reported, including but not limited to agitation, aggression, depression, sleep disturbances, and suicidal thoughts and behaviour including suicide.[1] The Warnings section additionally lists anxiousness, disorientation, attention disturbance, abnormal dreams, stuttering, hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, sleepwalking, tic and tremor.[1]
Balance, honestly stated. The boxed warning was driven largely by spontaneous adverse-event reports. Since then, a nationwide Swedish register cohort of 74,291 children and adolescents aged 6 to 17 compared montelukast users with long-acting beta-agonist users and found no increased risk of neuropsychiatric adverse events, with a weighted hazard ratio of 0.99 (95% CI 0.84 to 1.16).[4] Neither finding cancels the other. The warning stands and remains on the label; the population-level risk in children appears smaller than the reports suggested. The practical reading is: the drug is not to be feared, but it is also not to be taken casually for hay fever when simpler options exist.
What to do: anyone taking Montek-LC — or giving it to a child — should be told what to watch for, and should stop the drug and contact the prescriber if new agitation, sleep disturbance, mood change or unusual thoughts appear.[3]
Rare but serious
- Hypersensitivity reactions including anaphylaxis and angioedema to either active.[1][2]
- Systemic eosinophilia, sometimes with features of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome). The label notes these cases have usually, though not always, been associated with reduction of oral corticosteroid therapy — the association with montelukast itself has not been established.[1]
- Hepatic enzyme elevation.[1]
Pregnancy and breastfeeding
The old A/B/C/D/X pregnancy letter categories were withdrawn from US labelling and replaced by narrative risk summaries; the current montelukast label uses that narrative format, so the frequently repeated line that montelukast is “Category B” is no longer how the label reads.[1] Both labels state the drug should be used in pregnancy only if clearly needed, and levocetirizine is not recommended in nursing mothers because it is expected to be excreted in human milk.[1][2] This is a prescriber decision, not a self-medication decision.
Can Montek-LC be used for cough?
This is one of the most common searches around this brand, and the honest answer is conditional. Montek-LC has no approved indication for cough in either component label.[1][2] Where it helps is when the cough is a symptom of something the drug does treat — cough-variant asthma, allergic rhinitis with post-nasal drip, or airway hyper-reactivity. In those cases treating the underlying allergy settles the cough.
It will not help a cough caused by a viral infection, a bacterial chest infection, an ACE-inhibitor blood pressure tablet, reflux, or smoking. Taking an anti-allergic tablet for those simply delays the correct diagnosis. A cough lasting more than three weeks needs a doctor, not a repeat strip.
Who makes Montek-LC, and what else is the same thing?
Montek-LC is a brand of Sun Pharmaceutical Industries Ltd, India’s largest pharmaceutical company by market capitalisation.[8] The montelukast plus levocetirizine combination is not proprietary — many Indian manufacturers market the same two actives at the same strengths under their own brand names. These are therapeutically equivalent when made to the same pharmacopoeial standard; the differences are in excipients, dissolution profile and price.
| Brand | Marketed by | Composition |
|---|---|---|
| Montek-LC | Sun Pharmaceutical Industries Ltd | Montelukast 10 mg + levocetirizine 5 mg |
| Montair-LC | Cipla Ltd | Montelukast 10 mg + levocetirizine 5 mg |
| Zinte-M | Laafon Galaxy Pharmaceuticals | Montelukast 10 mg + levocetirizine 5 mg |
| Other generics | Multiple WHO-GMP certified Indian manufacturers | Montelukast 10 mg + levocetirizine 5 mg |
Do not switch brands on your own. Substitution should be a pharmacist or prescriber decision.
Price, and why brands differ so much
Montek-LC carries a maximum retail price of Rs 368.45 for a strip of 15 tablets, roughly Rs 24.56 per tablet, verified 29 August 2026.[9] Generic equivalents of the same composition typically sell for a fraction of that.
The reason the spread is so wide is regulatory, and it is rarely explained. The montelukast plus levocetirizine combination is not a scheduled formulation under the Drugs (Prices Control) Order, 2013 — no ceiling price has been fixed for it, so manufacturers set their own MRP within the annual price-increase limits for non-scheduled drugs. By contrast, the bilastine plus montelukast combination has had a retail price fixed, at Rs 21.22 per tablet, by order S.O. 2680(E) dated 27 May 2026.[10] Two very similar products, two entirely different pricing regimes.
Is there a better combination?
Possibly, and it is worth asking. In a prospective randomised open-label study at an Indian centre comparing montelukast plus bilastine against montelukast plus levocetirizine over 4 weeks in adults with allergic rhinitis, symptom-score reduction was equivalent between the two (p = 0.86), but adverse events were significantly more frequent in the levocetirizine arm (p = 0.04), and the bilastine combination was more cost-effective.[6] A phase III multicentre Indian trial reached the same equivalence conclusion on efficacy.[11] If sedation is your main complaint with Montek-LC, that is a specific, evidence-backed alternative to raise with your doctor.
Prescription status in India
Both actives are Schedule H drugs. A Schedule H medicine must carry the Rx symbol on the pack and may be supplied by a retail pharmacy only against the prescription of a registered medical practitioner. That applies equally to online pharmacies. Repeating an old strip without review is not a legal supply, and with a boxed-warning drug it is not a sensible one either. If you want the full picture of what Schedule H means, we have written it up separately in our guide to Schedule H drugs and their restrictions in India.
Frequently asked questions
The two components work on completely different timescales. Levocetirizine reaches peak plasma concentration about 0.9 hours after an oral tablet, so the antihistamine relief of sneezing, itching and runny nose is felt within the first hours. Montelukast reaches peak concentration in 3 to 4 hours, but its anti-inflammatory benefit in rhinitis and asthma builds over days to weeks of consistent daily dosing. Judge the tablet after two to four weeks of regular use, not after the first dose.
Two reasons. The levocetirizine label specifies once daily in the evening, which places any mild drowsiness at night rather than during the working day. Separately, allergic rhinitis and asthma symptoms characteristically worsen overnight and in the early morning, so evening dosing puts the drug at its most useful when symptoms peak. Take it at the same time each day to keep plasma levels steady.
In controlled adult trials, somnolence was reported by 6% of patients taking levocetirizine 5 mg compared with 2% taking placebo. So roughly one extra person in twenty-five feels drowsy because of the drug. This is much less than older antihistamines such as chlorpheniramine or hydroxyzine, but it is not zero. Avoid alcohol and other sedatives while taking it, and see how you react before driving at night.
It is prescribed as long-term daily maintenance therapy and is used that way widely. The condition attached is review. Because montelukast carries a boxed warning for neuropsychiatric events, long-term use should include periodic reassessment of whether the drug is still needed, and prompt reporting of any change in mood, sleep or behaviour. For allergic rhinitis alone, the label directs prescribers to reserve montelukast for patients who cannot use or do not respond to alternatives, so an annual conversation about whether to continue is entirely reasonable.
Montek-LC is manufactured and marketed by Sun Pharmaceutical Industries Ltd, the largest Indian pharmaceutical company by market capitalisation. The same montelukast 10 mg plus levocetirizine 5 mg combination is sold by many other Indian manufacturers under different brand names, including Montair-LC from Cipla and Zinte-M from Laafon Galaxy Pharmaceuticals. The combination itself is not proprietary to any one company.
Not this strength. The 10 mg plus 5 mg tablet is for patients aged 12 years and over. For children aged 6 to 11 the levocetirizine dose must not exceed 2.5 mg daily, and children with any degree of renal impairment in the 6 months to 11 years band are a contraindication for levocetirizine altogether. Paediatric treatment needs an age-appropriate and weight-appropriate formulation chosen by a paediatrician, not a halved adult tablet.
For seasonal allergy, treatment is often stopped when the season ends, and that is planned with your prescriber. For asthma it is different: montelukast is a controller, and stopping it when you feel well can allow airway inflammation to return silently before symptoms do. Never stop an asthma controller without medical advice, and never treat this tablet as a substitute for a reliever inhaler during an attack.
Manufacturing this combination?
Laafon Galaxy Pharmaceuticals runs WHO-GMP compliant third-party manufacturing of anti-allergic tablets, including montelukast and levocetirizine combinations, with dossier and stability support. If you are a distributor or brand owner rather than a patient, this is the right door.
Third-party manufacturing enquiryReferences
- Organon LLC. SINGULAIR (montelukast sodium) tablets, chewable tablets and oral granules — full prescribing information. Revised June 2021. Bethesda, MD: DailyMed, US National Library of Medicine. Available from: dailymed.nlm.nih.gov. Accessed August 2026.
- UCB Inc. XYZAL (levocetirizine dihydrochloride) tablets and oral solution — full prescribing information. Bethesda, MD: DailyMed, US National Library of Medicine. Available from: dailymed.nlm.nih.gov. Accessed August 2026.
- US Food and Drug Administration. FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair). Drug Safety Communication, 4 March 2020. Silver Spring, MD: FDA. Available from: fda.gov. Accessed August 2026.
- Wintzell V, Brenner P, Halldner L, Rhedin S, Gong T, Almqvist C. Montelukast use and the risk of neuropsychiatric adverse events in children. JAMA Pediatr. 2025;179(4):418–427. Available from: doi.org/10.1001/jamapediatrics.2024.5429. Indexed in PubMed, PMID 39836401.
- Kim CK, Hwang Y, Song DJ, Yu J, Sohn MH, Park YM, et al. Efficacy and safety of montelukast + levocetirizine combination therapy compared to montelukast monotherapy for allergic rhinitis in children. Allergy Asthma Immunol Res. 2024;16(6):652–667. Available from: doi.org/10.4168/aair.2024.16.6.652. Indexed in PubMed, PMID 39622689.
- Dakhale GN, Chindhalore CA, Kumar M, Bidkar V. Effectiveness, safety, and cost-effectiveness of fixed-dose combination of montelukast-bilastine versus montelukast-levocetirizine in allergic rhinitis: a prospective, randomized, open-label, parallel-group study. Perspect Clin Res. 2025;16(4):198–204. Available from: doi.org/10.4103/picr.picr_206_24. Indexed in PubMed, PMID 41209771.
- Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2026 update. Available from: ginasthma.org. Accessed August 2026.
- Laafon Galaxy Pharmaceuticals. Top 10 pharma companies in India (2026) — by Nifty Pharma index weighting. Available from: laafon.com. Accessed August 2026.
- PharmEasy. Montek LC Tablet, strip of 15 tablets — product listing and maximum retail price. Price verified 29 August 2026. Available from: pharmeasy.in.
- Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. Order S.O. 2680(E) dated 27 May 2026 fixing retail prices of formulations under the Drugs (Prices Control) Order, 2013. National Pharmaceutical Pricing Authority. Available from: nppaindia.nic.in. Accessed August 2026.
- Sinha SD, Perapogu S, Chary S S, Ramesh S, Bakshi J, Singh A, et al. Efficacy and safety of fixed-dose combination of bilastine-montelukast in adult patients with allergic rhinitis: a phase III, randomized, multi-center, double-blind, active controlled clinical study. J Asthma. 2023;60(11):2014–2020. Available from: doi.org/10.1080/02770903.2023.2209175. Indexed in PubMed, PMID 37140964.
Clinical trial references retrieved via PubMed, US National Library of Medicine.
Medical disclaimer. This article is educational and technical in nature. It is not medical advice, and it does not replace consultation with a registered medical practitioner or pharmacist. Montek-LC is a prescription-only (Schedule H) medicine and must not be self-medicated, shared, or continued without review. Dosage, contraindications and safety information are summarised from approved prescribing information and may differ between the Indian pack insert and the US label cited here — always follow the pack insert supplied with your medicine and your prescriber’s instructions.
Reporting side effects. Suspected adverse drug reactions in India can be reported to the Pharmacovigilance Programme of India through your treating doctor or hospital ADR monitoring centre.
Written and reviewed by Darshan Singh, co-founder and regulatory consultant at Laafon Galaxy Pharmaceuticals, with over 23 years in pharmaceutical quality control, quality assurance and drug regulatory affairs.
