Fexofenadine Tablet: Uses, Dose, Side Effects and Top Brands in India (2026)

• Updated 23 October 2026
• Reviewed by Sudhanshu Singhal
• 20 min read
• 36 sources

Prices are as shown on Tata 1mg on 23 October 2026; prices change over time, so the MRP printed on the pack governs.

What is fexofenadine?

Fexofenadine hydrochloride is an antihistamine — in the label's words "a histamine H1-receptor antagonist" with selective H1-receptor antagonist activity — and the major active metabolite of terfenadine. The NHS describes it in plain words as "a non-drowsy antihistamine" that blocks the effects of histamine and so reduces allergy symptoms.

In laboratory animals the US label found no anticholinergic or alpha1-adrenergic blocking effects and no sedative or other central nervous system effects, and radiolabelled studies in rats indicated that fexofenadine "does not cross the blood-brain barrier". In people, histamine skin-wheal studies in the US label show the antihistamine effect starting within 1 hour, peaking at 2 to 3 hours and still present at 12 hours; the NHS says most people start to feel better within 1 to 2 hours.

Forms and strengths sold in India

• Tablets IP of fexofenadine hydrochloride 120 mg and 180 mg, film-coated, as in the Allegra abridged prescribing information (Sanofi India, updated December 2023).
• Oral suspension: each 5 ml (one teaspoonful) contains fexofenadine hydrochloride IP 30 mg in a flavoured syrup base. The bottle should be shaken well before each use.
• Fixed-dose combinations with montelukast: a tablet of montelukast 10 mg + fexofenadine 120 mg (for example Allegra-M and Montair FX) and a suspension of montelukast 4 mg + fexofenadine 30 mg per 5 ml (for example Vitaresp FX), as listed on Tata 1mg.

Strengths differ by country — the US label lists 30 mg, 60 mg and 180 mg tablets and a 30 mg per 5 ml suspension, UK Telfast sells 30 mg, 120 mg and 180 mg tablets, while the Indian Allegra label lists 120 mg and 180 mg tablets and the 30 mg per 5 ml suspension.

What montelukast adds to the combination

Montelukast binds with high affinity and selectivity to the cysteinyl leukotriene type-1 (CysLT1) receptor and blocks the actions of leukotrienes at that receptor. In allergic rhinitis, cysteinyl leukotrienes are released from the nasal mucosa after allergen exposure in both early- and late-phase reactions and are associated with the symptoms (US Singulair label); fexofenadine blocks histamine, while montelukast blocks leukotrienes. The Singulair label adds that montelukast "does not contain a steroid", and that montelukast 10 mg once daily "did not change the plasma concentration profile of fexofenadine", so no dose adjustment is needed for fexofenadine when the two are used together.

What is it used for?

As stated in the Indian label (Sanofi Allegra abridged prescribing information, December 2023), fexofenadine tablets are "indicated for relief of symptoms associated with allergic rhinitis and chronic idiopathic urticaria", and the suspension is indicated for relief of symptoms of allergic rhinitis in children 2 to 11 years and for the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 11 years.

Other labels use similar wording. The UK Telfast 120 mg SmPC states the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years and older, and the Telfast 180 mg SmPC states the relief of symptoms associated with chronic idiopathic urticaria in the same age group. The US over-the-counter label says the product "temporarily relieves symptoms of hay fever or other upper respiratory allergies" — runny nose, sneezing, itchy or watery eyes, and itching of the nose or throat.

Montelukast has its own approved uses in the US Singulair label: prophylaxis and chronic treatment of asthma from 12 months of age, prevention of exercise-induced bronchoconstriction from 6 years, and seasonal allergic rhinitis from 2 years and perennial allergic rhinitis from 6 months. For allergic rhinitis the label says to "reserve use for patients who have an inadequate response or intolerance to alternative therapies", and montelukast is not indicated for an acute asthma attack.

Indian product listings describe the montelukast + fexofenadine combinations for sneezing and runny nose due to allergies. Fexofenadine and montelukast sodium are listed under Schedule H of the Drugs and Cosmetics Rules, 1945 (as amended up to 30 September 2020), so they must be taken only as prescribed by a doctor, for the condition the doctor has diagnosed. This page gives information only and does not replace medical advice.

Dose as stated in the labels

The usual doses below are quoted from each source exactly as that label states them, and you must always take fexofenadine exactly as your doctor prescribes; the pack in your hand governs.

India (Sanofi Allegra abridged prescribing information, December 2023)

• Allergic rhinitis, adults and children 12 years and over: "120mg once daily or 180mg once daily"; with decreased renal function the starting dose is 60 mg once daily.
• Allergic rhinitis, children 2 to 11 years: 30 mg twice daily (5 ml of suspension contains 30 mg), with 30 mg once daily as the starting dose in decreased renal function.
• Chronic urticaria: adults and children 12 years and over, 180 mg once daily; children 2 to 11 years, 30 mg (5 ml) twice daily; children 6 months to under 2 years, 15 mg (2.5 ml) twice daily.
• No dose adjustment is needed in elderly patients or in patients with liver impairment; the suspension bottle should be shaken well before each use.

UK (Telfast SmPC and NHS)

• Telfast 120 mg: "120 mg once daily taken before a meal" for adults and children 12 years and older. Telfast 180 mg: "180 mg once daily taken before a meal"; this strength "has not been studied in children under 12".
• NHS: for hay fever, children 6 to 11 years take 30 mg twice daily; for hives, 180 mg once daily from 12 years.
• The 120 mg and 180 mg tablets are to be taken before a meal, with water; 30 mg tablets can be taken with or without food.
• Missed dose on a once-daily regimen: take it as soon as you remember unless it is nearly time for the next dose. "Do not take 2 doses to make up for a forgotten dose."
• Studies in special risk groups indicate no dose adjustment in older people or in renal or hepatic impairment, but the SmPC adds that data in these groups are limited.

US (FDA labels)

The US prescription label for 12 years and older states "60 mg twice daily or 180 mg once daily with water", with 60 mg once daily as the starting dose in decreased renal function, and states that the 180 mg once-daily dose is "not for use in patients with decreased renal function". For children 6 to 11 years it states 30 mg twice daily; the suspension is 30 mg twice daily for 2 to 11 years and 15 mg (2.5 ml) twice daily for urticaria in children 6 months to under 2 years. The US over-the-counter 24 Hour (180 mg) label says to take one tablet "with water once a day", no more than one tablet in 24 hours.

Timing, food and drink

Take the tablets with plain water. The US prescription label says fruit juices such as grapefruit, orange and apple "may reduce the bioavailability and exposure of fexofenadine" — bioavailability was reduced by 36% in a population analysis — and therefore tablets "should be taken with water"; the US over-the-counter label says "do not take with fruit juices", and the NHS advises the same. The UK SmPC and leaflet do not mention fruit juice. Antacids containing aluminium or magnesium should be taken 2 hours before or after fexofenadine (Indian label).

Montelukast and the combinations

The montelukast + fexofenadine tablet and suspension are taken as the doctor prescribes. The Singulair label gives montelukast's own regimens: for allergic rhinitis, one 10 mg tablet once daily from 15 years, one 5 mg chewable tablet for 6 to 14 years, one 4 mg chewable tablet or granule packet for 2 to 5 years, and one 4 mg granule packet for perennial rhinitis in 6 to 23 months, taken once daily "without regard to time of food ingestion"; for asthma, once daily in the evening. Never take a double dose to make up for a missed one.

Side effects

Headache is the most frequent side effect on the Indian label (more than 3% of patients), with drowsiness, dizziness and nausea at 1 to 3%. The UK SmPC lists headache, drowsiness, dizziness and nausea as "common" (the patient leaflet defines common as up to 1 in 10 people) and fatigue as "uncommon" (up to 1 in 100), while the NHS puts sleepiness, feeling sick, headaches and dizziness at more than 1 in 100 people.

Frequencies reported in the US label

• Adults and adolescents with seasonal allergic rhinitis taking 180 mg once daily: headache 10.3% versus 7.2% on placebo; back pain 2.5% versus 1.4%.
• Chronic idiopathic urticaria taking 180 mg once daily: headache 4.8% versus 3.3% on placebo; taking 60 mg twice daily: dizziness, back pain, stomach discomfort and pain in extremity each 2.1%.
• Children 6 to 11 years taking 30 mg twice daily: cough 3.8% versus 1.3% on placebo, upper respiratory infection 2.9% versus 0.9%, pyrexia 2.4% versus 0.9%, otitis media 2.4% versus 0.0%.
• Children 6 months to 5 years: somnolence or fatigue in 1.3% overall versus 0.2% on placebo.

The UK SmPC also lists, with frequency not known: blurred vision, hypersensitivity reactions (angioedema, anaphylaxis), insomnia, nervousness, sleep disorders or nightmares, tachycardia, palpitations, diarrhoea, rash, urticaria and pruritus.

Serious reactions — get urgent medical help

Post-marketing reports in the US label include hypersensitivity reactions such as anaphylaxis, urticaria, angioedema, chest tightness, breathlessness, flushing, pruritus and rash. MedlinePlus says to call a doctor for hives, rash, itching, trouble breathing or swallowing, or swelling of the face or throat, and the NHS says to report a fast or irregular heartbeat to a doctor. Dry mouth is not listed as a side effect in any fexofenadine label read; it appears only in overdose sections, which report "dizziness, drowsiness, and dry mouth" with fexofenadine overdose.

Montelukast carries a boxed warning

The US Singulair label carries a boxed warning that "Serious neuropsychiatric (NP) events have been reported", including agitation, aggression, depression, sleep disturbances and suicidal thoughts and behaviour (including suicide), as well as hallucinations, irritability, memory impairment, restlessness, sleepwalking and tremor. The label advises patients and caregivers to be alert for behaviour changes or new neuropsychiatric symptoms and, if they occur, to discontinue montelukast and contact a healthcare provider immediately. The FDA announcement of 4 March 2020 strengthened these warnings because "many health care professionals and patients/caregivers are not aware of the risk".

Who should not take it, and interactions

Fexofenadine must not be taken by anyone with a known hypersensitivity to fexofenadine or to any ingredient of the product (Indian label, US label, UK SmPC), and montelukast is contraindicated in hypersensitivity to any of its components.

Key interactions

• Antacids with aluminium or magnesium: take them 2 hours before or after fexofenadine (Indian label). The US label shows that 120 mg given within 15 minutes of such an antacid lowered fexofenadine exposure by about 41% (AUC) and 43% (Cmax).
• Erythromycin and ketoconazole (P-glycoprotein inhibitors) raised fexofenadine plasma levels 2 to 3 times in the UK SmPC; the Indian label reports no significant QTc increase with either, and the US label saw no differences in adverse events or QTc interval.
• Apalutamide, a P-glycoprotein inducer, cut fexofenadine AUC by 30% and Cmax by 7% after a single 30 mg dose; no interaction was seen with omeprazole (Indian label). The NHS also lists leflunomide, velpatasvir, teriflunomide and apalutamide.
• Fruit juices — grapefruit, orange and apple — may reduce the bioavailability and exposure of fexofenadine (US label), so tablets are taken with water as the US labels and NHS advise.
• Alcohol: the NHS says "It's best not to drink alcohol while you're taking fexofenadine, as it can make you feel sleepy."

Check with your doctor first

The NHS asks patients to check with a doctor before use if they have had an allergic reaction to fexofenadine before, have liver or kidney problems, heart problems or an upcoming allergy test, or are pregnant or breastfeeding. The UK SmPC notes that antihistamines as a class are linked with tachycardia and palpitations, so patients with cardiovascular disease should be warned. In decreased renal function the Indian and US labels lower the adult starting dose to 60 mg once daily, and the US label says safety and effectiveness are not established under 6 months of age.

Pregnancy and breastfeeding

Pregnancy: the Indian label says fexofenadine is "used only if the potential benefit outweighs the potential risk"; the US label says there are no adequate studies in pregnant women and use is only if the benefit justifies the risk; the UK SmPC says it "should not be used during pregnancy unless clearly necessary", and the NHS says it is not usually recommended in pregnancy and other antihistamines may be more suitable. Breastfeeding: the sources differ — the US label says it is not known whether fexofenadine is excreted in human milk and to use caution, the UK SmPC says it is not recommended for mothers breastfeeding, and the NHS says only tiny amounts get into breast milk and that the baby should be watched for poor feeding or unusual sleepiness.

For montelukast, decades of published cohort data "have not established a drug-associated risk of major birth defects", and data "do not suggest a significant risk" to breastfed infants (Singulair label). Other montelukast cautions from its label: it is not for an acute asthma attack, care is needed with aspirin sensitivity and eosinophilic conditions, chewable tablets contain phenylalanine, and the FDA asks patients to tell the health professional about any history of mental illness before starting.

Rules in India

Fexofenadine and montelukast sodium are both listed as prescription drugs under Schedule H of the Drugs and Cosmetics Rules, 1945 (as amended up to 30 September 2020): "Fexofenadine" is item 197 and "Montelukast sodium" is item 336 in the Schedule H list, and every fexofenadine and montelukast + fexofenadine brand page read on Tata 1mg shows "Prescription required".

Neither drug is named in Schedule G, whose antihistamine list names chlorpheniramine, diphenhydramine, promethazine and similar substances, and the Rules text read has no "OTC" sale category.

NLEM 2022

Fexofenadine does not appear anywhere in the National List of Essential Medicines 2022 (notified by S.O. 5249(E), Gazette of India Extraordinary, 11 November 2022). Montelukast is listed at item 24.1.5 under "Antiasthmatic Medicines" as tablet 4 mg, tablet 5 mg including chewable tablets, and tablet 10 mg, at levels S and T; cetirizine is listed at item 3.2. The montelukast + fexofenadine combinations are not in NLEM.

NPPA ceiling prices

Because fexofenadine is not on NLEM, no NPPA ceiling price is expected for its formulations, and one price listing shows "Price-controlled 0 of 155 packs" for the molecule. For montelukast tablets, a price page (Counterfoil) shows ceiling prices of ₹16.84 per 10 mg tablet, ₹12.30 per 5 mg tablet and ₹10.48 per 4 mg tablet under an order dated 25 March 2026, plus taxes. No NPPA ceiling price was found for the montelukast + fexofenadine combination, and the MRP printed on the pack governs.

Brands listed in India

The table at the top of this page lists the fexofenadine and montelukast + fexofenadine brands found on Tata 1mg, with the marketer shown there, the pack and the price as displayed on 23 October 2026. No sales-ranking source was used, so this is a listing and not a ranking; always rely on the MRP printed on the strip or bottle.

The Vibcare range

Vibcare Pharma markets 10 products in 5 compositions in this segment: fexofenadine 120 mg and 180 mg tablets, fexofenadine hydrochloride 30 mg per 5 ml oral suspension, montelukast 10 mg + fexofenadine 120 mg tablets, and fexofenadine 30 mg + montelukast 4 mg per 5 ml suspension, across its Auspin, Prima, Evermed and Medanor divisions.

This range is available to Vibcare PCD franchise partners with monopoly rights in their district; see our Respiratory PCD franchise and PCD pharma franchise pages.

Frequently asked questions

Sources

Related reading

• About Vibcare Pharma
• Vibcare manufacturing and WHO-GMP facility
• PCD pharma franchise with Vibcare