Does montelukast contain wheat or gluten as an excipient?

We cross-check each montelukast product label against four data sources: DailyMed (FDA Structured Product Labels), the European Medicines Agency centrally-authorised medicines database, the Plogsted curated gluten-free drug list, and the 2024 Mangione et al. pediatric pharmacy NDC analysis. Inactive ingredients are scanned against a 146-entry red-flag dictionary covering wheat, barley, rye, malt, source-ambiguous starches, and FDA gluten-free attestation phrases. Mostly yes — but worth a quick call to the manufacturer for some generics. Of 18 product labels we checked, 10 are clean, 5 are confirmed gluten-free by the maker, and 3 contain an inactive ingredient (typically a source-ambiguous starch) whose botanical origin isn't fully disclosed. None contained confirmed gluten.

Can different manufacturers' generic versions of montelukast have different gluten status?

Yes. Generics in the United States must use the same active ingredient as the brand, but they are not required to use the same inactive ingredients. Two generics of montelukast from different manufacturers can use entirely different starch sources, binders, and fillers. A pharmacy may also switch which manufacturer it dispenses between fills without notifying you. Each manufacturer-specific entry below corresponds to a separately-filed product label.

Last verified May 17, 2026 · 18 product labels screened

Is montelukast gluten-free?

Looks mostly clean — worth verifying with the maker. Mostly yes — but worth a quick call to the manufacturer for some generics. Of 18 product labels we checked, 10 are clean, 5 are confirmed gluten-free by the maker, and 3 contain an inactive ingredient (typically a source-ambiguous starch) whose botanical origin isn't fully disclosed. None contained confirmed gluten.

Drug context

About montelukast

Montelukast is a leukotriene receptor antagonist used for asthma and allergic rhinitis, sold under brand names including Singulair.

Why this matters

Different manufacturers, different ingredients

Generics of montelukast use the same active ingredient, but they aren't required to use the same inactive ingredients. Your pharmacy may switch which manufacturer they dispense between fills, sometimes without telling you. The list below shows each manufacturer's product label as a separate entry, because that's the granularity that actually matters when you're celiac.

The labels

The 18 we checked

01

Mylan manufacturer-attested gluten-free

Plogsted list · Montelukast 10 mg Tablet [Mylan] · label dated 2019-04-23

Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label →
02

Teva manufacturer-attested gluten-free

Plogsted list · Montelukast 10 mg Tablet [Teva] · label dated 2019-04-23

Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label →
03

Mylan manufacturer-attested gluten-free

Plogsted list · Montelukast Chewable both strengths [Mylan] · label dated 2019-04-23

Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label →
04

Teva manufacturer-attested gluten-free

Plogsted list · Montelukast Chewable both strengths (corn maltodextrin) [Teva] · label dated 2019-04-23

Manufacturer confirmed gluten-free (Plogsted 2019-04-23)

Worth a call to the maker: Maltodextrin
View source label →
05

Mylan manufacturer-attested gluten-free

Plogsted list · Montelukast Granule [Mylan] · label dated 2019-04-23

Manufacturer confirmed gluten-free (Plogsted 2019-04-23)
View source label →
06

Accord worth a call to confirm

Plogsted list · Montelukast 10 mg Tablet [Accord] · label dated 2019-04-23
View source label →
07

Apotex worth a call to confirm

Plogsted list · Montelukast 10 mg Tablet [Apotex] · label dated 2019-04-23
View source label →
08

Aurobindo worth a call to confirm

Plogsted list · Montelukast 10 mg Tablet [Aurobindo] · label dated 2019-04-23
View source label →
09

Ajanta Pharma USA Inc. nothing flagged on the label

US label (DailyMed) · MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONT… · label dated May 11, 2026

Inactive ingredients ASPARTAME · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE
View source label →
10

Torrent Pharmaceuticals Limited nothing flagged on the label

US label (DailyMed) · MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM GRANUL… · label dated Mar 09, 2026

Inactive ingredients ASPARTAME · CELLULOSE, MICROCRYSTALLINE · CHERRY · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSE 2910 (6 MPA.S) · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · SODIUM PHOSPHATE, TRIBASIC · TITANIUM DIOXIDE
View source label →
11

Redpharm Drug nothing flagged on the label

US label (DailyMed) · MONTELUKAST SODIUM TABLET, FILM COATED [REDPHARM DRUG] · label dated Dec 31, 2025

Inactive ingredients CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (TYPE L) · HYPROMELLOSE 2910 (6 MPA.S) · MAGNESIUM STEARATE · POLYETHYLENE GLYCOL 6000 · TITANIUM DIOXIDE
View source label →
12

Chartwell RX, LLC nothing flagged on the label

US label (DailyMed) · MONTELUKAST SODIUM TABLET, CHEWABLE [CHARTWELL RX, LLC] · label dated Dec 19, 2025

Inactive ingredients BUTYLATED HYDROXYANISOLE · CELLULOSE, MICROCRYSTALLINE · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSES · MANNITOL · SILICON DIOXIDE · SODIUM STEARYL FUMARATE · SUCRALOSE
View source label →
13

Sandoz Inc nothing flagged on the label

US label (DailyMed) · MONTELUKAST TABLET, FILM COATED [SANDOZ INC] · label dated Nov 17, 2025

Inactive ingredients CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE, UNSPECIFIED · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MICROCRYSTALLINE CELLULOSE · POLYETHYLENE GLYCOL, UNSPECIFIED · TITANIUM DIOXIDE
View source label →
14

Amneal Pharmaceuticals LLC nothing flagged on the label

US label (DailyMed) · MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS LLC] · label dated Nov 17, 2025

Inactive ingredients CELLULOSE, MICROCRYSTALLINE · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · FERROSOFERRIC OXIDE · HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED · HYPROMELLOSES · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · TITANIUM DIOXIDE
View source label →
15

Organon LLC nothing flagged on the label

US label (DailyMed) · SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE … · label dated Jun 25, 2025

Inactive ingredients ASPARTAME · CARNAUBA WAX · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE (1600000 WAMW) · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE
View source label →
16

Camber Pharmaceuticals, Inc. nothing flagged on the label

US label (DailyMed) · MONTELUKAST SODIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · label dated Jun 04, 2025

Inactive ingredients CARNAUBA WAX · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE · HYPROMELLOSE, UNSPECIFIED · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · MICROCRYSTALLINE CELLULOSE · TITANIUM DIOXIDE
View source label →
17

Amneal Pharmaceuticals LLC nothing flagged on the label

US label (DailyMed) · MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE [AMNEAL PHARMACEUTICALS LLC] · label dated Apr 21, 2025

Inactive ingredients ASPARTAME · CELLULOSE, MICROCRYSTALLINE · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED · MAGNESIUM STEARATE · MANNITOL
View source label →
18

Quallent Pharmaceuticals Health LLC nothing flagged on the label

US label (DailyMed) · MONTELUKAST (MONTELUKAST) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] · label dated Mar 03, 2025

Inactive ingredients CARNAUBA WAX · CELLULOSE, MICROCRYSTALLINE · CROSCARMELLOSE SODIUM · FERRIC OXIDE RED · FERRIC OXIDE YELLOW · HYDROXYPROPYL CELLULOSE · HYPROMELLOSES · LACTOSE MONOHYDRATE · MAGNESIUM STEARATE · MANNITOL · TITANIUM DIOXIDE
View source label →

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Background

What “gluten in a medication” actually means

Gluten enters drugs through their excipients — the inactive ingredients used to bind, coat, fill, or stabilize the dose. The main concern is wheat starch as a filler. Source-ambiguous starches (plain “starch”, pregelatinized starch, sodium starch glycolate, modified starch) get flagged for verification because their botanical origin isn't always disclosed on the label.

The 2024 Mangione et al. pediatric NDC analysis (689 NDCs across the top 100 pediatric medications) found 1.5% contained gluten outright; another 25.7% couldn't be confirmed either way. Liquid and oral-suspension formulations carry disproportionate risk because wheat starch is a common thickener. Full methodology →

Keep checking

Other drugs people look up

Important. This page is informational. Drug labels can change without notice; a manufacturer attestation is point-in-time, not a warranty. If you have celiac disease and your pharmacy switches manufacturers, re-screen the new label before taking the dispensed product. For a definitive answer, call the manufacturer's medical-information line with the NDC code from your prescription bottle.