Product information · reviewed 2 November 2026
FTOX-AM Syrup is an ambroxol, terbutaline, guaiphenesin and menthol syrup: a prescription-only fixed-dose combination of ambroxol hydrochloride 15 mg, terbutaline sulphate 1.25 mg, guaiphenesin 50 mg and menthol 2.5 mg in each 5 mL, used for wet (productive) cough with tight or narrowed airways. It is marketed by Laafon Galaxy Pharmaceuticals.
- Rx only · Schedule H
- Not for children under 6
- Not on India’s banned-FDC lists (checked 2 Nov 2026)
- Brand
- FTOX-AM Syrup
- Pack
- 100 mL PET bottle
- MRP
- ₹92 per 100 mL
- Marketed by
- Laafon Galaxy Pharmaceuticals
- Manufactured at
- A third-party WHO-GMP unit
- Shelf life · storage
- 24 months · below 25 °C, away from light and moisture
The MRP shown is the price printed on current stock. Laafon Galaxy markets FTOX-AM; it is manufactured for us at a third-party WHO-GMP certified facility. It is prescription-only because terbutaline sulphate is on the Schedule H drugs list. See all Laafon Galaxy products for the rest of the range.
Ambroxol, terbutaline, guaiphenesin and menthol syrup: what is in each 5 mL
Each ingredient does a different job. Two of them act on the mucus, one opens the airways and one gives a cooling feel in the throat. To see how this formula compares with other brands, read our guide to wet cough syrup brands and compositions in India.
Scroll the table sideways →
| Ingredient | Per 5 mL | Class | What it does |
|---|---|---|---|
| Ambroxol hydrochloride | 15 mg | Mucolytic (secretolytic) | Thins sticky mucus and stimulates surfactant release in the lungs[1] |
| Terbutaline sulphate | 1.25 mg | Beta-agonist bronchodilator | Relaxes and opens the airways[2] |
| Guaiphenesin (guaifenesin) | 50 mg | Expectorant | Thins mucus in the air passages so it is easier to cough up[3] |
| Menthol | 2.5 mg | Cooling agent | Activates the TRPM8 cold receptor, which gives the cooling sensation[4] |
How the four ingredients work
Ambroxol
Ambroxol is the active metabolite of bromhexine[5]. It stimulates synthesis and release of surfactant by type II pneumocytes and inhibits the nitric-oxide-dependent activation of soluble guanylate cyclase[1]. Its half-life is 7 to 12 hours and it is about 90% protein-bound[1].
Terbutaline
Terbutaline is a beta-agonist. It relaxes and opens the airways, which eases wheezing and chest tightness; it controls symptoms but does not treat the underlying condition[2]. It is the ingredient that makes FTOX-AM a Schedule H medicine; it is not in the Schedule H1 drug list, so the separate H1 sale register does not apply.
Guaiphenesin
An expectorant that thins mucus in the air passages. MedlinePlus notes it may help control symptoms but does not treat the cause or speed recovery[3].
Menthol
Menthol selectively activates the TRPM8 channel, the receptor behind the sensation of coolness[4]. In this syrup it acts on comfort, not on the mucus.
FTOX-AM syrup uses
Leaflets for this four-ingredient combination list it for cough with mucus where the airways are narrowed: asthma, bronchospasm and reversible airways obstruction, to loosen mucus and ease coughing[6]. A doctor decides whether that applies to a given patient. For how cough syrups are chosen and sold under the 2026 rules, see how to choose a cough syrup in India in 2026.
Suited to
- Wet (productive) cough with thick, hard-to-clear mucus
- Cough with wheeze or chest tightness, where a doctor wants an oral bronchodilator
- Patients who cannot use an inhaler or prefer a liquid[6]
Not suited to
- Dry, tickly cough with no mucus (see dry cough syrups for adults instead)
- Acute severe asthma attacks, which need urgent care
- Long-standing cough from smoking, asthma or emphysema, unless a doctor directs[3][6]
- Use alongside a cough suppressant[6]
FTOX-AM syrup dose by age
FTOX-AM is a prescription medicine, so the dose on the prescription and the carton comes first. The guidance below follows the dosing printed for this composition in an Indian product leaflet (same four ingredients; that product has ambroxol 20 mg and menthol 0.5 mg)[6], and the Health Ministry’s October 2025 advisory on cough syrups for children[7].
1. Who is the syrup for?
2. Heart disease, high blood pressure, overactive thyroid, diabetes or seizures?
Choose an age group to see the guidance
The answer appears here. It does not replace the prescription.
Scroll the table sideways →
| Age | Guidance | Basis |
|---|---|---|
| Under 2 years | Do not give. Cough and cold medicines should not be prescribed or dispensed at this age. | MoHFW advisory, 3 Oct 2025[7] |
| 2 to 5 years | Not recommended. | MoHFW: generally not recommended under 5[7]; leaflet: not recommended under 6[6] |
| 6 to 11 years | Only as a doctor prescribes, after a clinical check. The leaflet range for 6 to 12 years is 5 to 10 mL three times a day. | Leaflet[6]; MoHFW: close supervision, avoid multiple-drug combinations[7] |
| 12 years and adults | 10 mL three times a day | Leaflet[6] |
| Older adults | May need a lower dose; more sensitive to terbutaline. | Leaflet[6] |
How long? See the doctor again if the cough is not better within 7 days, or if high fever, rash or a persistent headache appears[3]. Use the measuring cup supplied, not a kitchen spoon. If a dose is missed, skip it and take the next one on time; do not double up[6].
For the full set of 2026 age rules for children’s cough syrups, see our guide to cough syrup for children in India and the 2026 age rules.
Who should not take FTOX-AM, and drug interactions
Do not use if
Scroll the table sideways →
| Taken with | What can happen | What to do |
|---|---|---|
| Cough suppressants (for example dextromethorphan) | Loosened mucus may not clear, causing blockage of the airways by secretions[6] | Do not combine |
| Non-selective beta-blockers (for example propranolol) | Oppose terbutaline’s action[6] | Must not be given together[6] |
| MAO inhibitors or tricyclic antidepressants, now or in the past 2 weeks | Effects on blood vessels may be increased[6][2] | Only with extreme caution, under a doctor |
| Other sympathomimetics (decongestants, other bronchodilators) | Added heart and blood-pressure effects[6] | Use with caution |
| Cold tablets containing ambroxol, guaiphenesin or phenylephrine, such as Laricold tablet | Doubles up ambroxol and guaiphenesin, and phenylephrine adds to terbutaline’s heart and blood-pressure effects[6] | Do not take together unless the doctor prescribes both |
| Warfarin | Menthol may reduce warfarin’s effect[6] | Tell the doctor; INR may need checking |
| Amoxicillin, cefuroxime, erythromycin | Ambroxol raises their levels in bronchial secretions and sputum[6] | No action needed; noted for prescribers |
FTOX-AM syrup side effects
Common
- From terbutaline: tremor, headache, fast heartbeat or palpitations, muscle cramps, low potassium[6]; nervousness, poor sleep, sweating, dizziness[2]
- From ambroxol: nausea, numbness in the mouth or throat, indigestion, dry mouth, stomach pain[6]
- From guaiphenesin: stomach upset, nausea, vomiting[6][3]
Stop and get medical help
- Rash that spreads, skin swelling or blistering. In 2015 EMA confirmed a small risk of severe skin reactions (including erythema multiforme and Stevens-Johnson syndrome) and a low risk of anaphylaxis with ambroxol and bromhexine[5]
- Chest pain, fast or irregular heartbeat, worse breathing, throat tightness or a seizure[2]
Pregnancy and breastfeeding
Pregnancy
There are no adequate, well-controlled studies of this combination in pregnancy; use only if a doctor judges it necessary[6]. Terbutaline must not be used to stop or prevent premature labour: used that way it has caused serious side effects, including death, in pregnant women[2].
Breastfeeding
Terbutaline passes into breast milk, but effects on the baby are unlikely at normal doses; brief low blood sugar has been reported in preterm newborns after the mother took a beta-2 agonist. Guaiphenesin passes into milk in small amounts[6]. A doctor should weigh the benefit.
The old US FDA letter categories (A, B, C) that some websites still quote for these ingredients were withdrawn for prescription drug labels, and ambroxol never had one because it is not a US-approved medicine. We do not use them.
Is ambroxol, terbutaline, guaiphenesin and menthol syrup banned in India?
No. This exact four-ingredient combination does not appear in the September 2018 (328 FDCs), June 2023 (14 FDCs) or August 2024 (156 FDCs) prohibition lists[8][9][10]. Very similar syrups do. One extra ingredient changes the answer, so always read the full composition.
Ambroxol + Terbutaline + Guaiphenesin + Menthol. Not on the 2018, 2023 or 2024 prohibition lists[8][9][10]. Terbutaline sulphate is listed in Schedule H of the Drugs Rules, 1945[11], so the syrup is sold only on a doctor’s prescription everywhere in India; it is central law, not a state-by-state rule.
G.S.R. 477(E), dated 9 June 2026, has also removed “Syrups” from the Schedule K household-remedy exemption[12]. For FTOX-AM nothing changes, because the Schedule H ingredient already made it prescription-only.
Ambroxol + Terbutaline + Ammonium chloride + Guaiphenesin + Menthol. Prohibited in the August 2024 batch of 156 FDCs, notified in the Gazette of India on 12 August 2024[10]. Same four ingredients as FTOX-AM plus ammonium chloride.
Cetirizine + Terbutaline + Ambroxol + Guaiphenesin. Prohibited in the same August 2024 batch[10]. Adding an antihistamine to an expectorant-bronchodilator combination is one of the patterns the 2024 review rejected.
Terbutaline + Ambroxol + Guaiphenesin + Zinc + Menthol. Prohibited in the September 2018 batch of 328 FDCs[8]. The same 2018 list also prohibited Ambroxol + Terbutaline + Dextromethorphan[8].
Levosalbutamol + Ambroxol + Guaiphenesin. The levosalbutamol 0.5 mg + ambroxol 15 mg + guaiphenesin 50 mg per 5 mL syrup appears on CDSCO’s 2018 list of FDCs issued an NOC, for bronchospasm in bronchial asthma and chronic bronchitis[13]. Laafon’s own levosalbutamol-based syrup is Cozicof-LS (levosalbutamol, ambroxol and guaiphenesin syrup).
The full 2024 list, with every S.O. number, is on our page of the 156 FDCs banned in 2024. For what Schedule H means for prescribing, dispensing and record-keeping, see Schedule H drugs: regulations and restrictions in India.
What the evidence does and does not show
No clinical trial of this exact four-ingredient syrup is indexed in PubMed. A search on 2 November 2026 for ambroxol + terbutaline + guaifenesin returned one paper, and it is an HPLC assay method for the three actives, not a clinical study[14]. Any claim of trial results for this combination needs a published source.
- Ambroxol in children: a 2020 review of studies covering almost 1,300 paediatric patients reported consistent benefit and good tolerability. Most studies predate Good Clinical Practice, and two of the six authors work for an ambroxol manufacturer[15].
- Ambroxol in adults: a 2018 safety review found adverse events mild and self-limiting and the risk of severe skin reactions low; it too was co-authored by manufacturer staff[16].
- Guaiphenesin: helps symptoms but does not treat the cause or shorten the illness[3].
We removed an earlier version of this page’s “Phase IV trial” table, efficacy star ratings and pharmacy-survey percentages because no source for them could be found.
Oral liquid quality: DEG and EG testing
On 13 October 2025 WHO issued Medical Product Alert N°5/2025 after CDSCO reported diethylene glycol (DEG) in specific batches of three Indian oral liquids: COLDRIF, Respifresh TR and ReLife[17]. In the same month the DCGI directed State and UT Drug Controllers to enforce testing of every batch of excipients, APIs and finished formulations before release, under Rules 74(c) and 78(c)(ii) of the Drugs Rules, 1945[18].
For trade buyers of any cough syrup
- Ask for the batch certificate of analysis, and check that it covers the finished product, not just the API.
- Check that the batch number, manufacturing date and expiry on the CoA match the carton.
- Buy only through licensed distributors, as WHO advises[17].
- Manufacturers: DEG and EG enter through excipients such as glycerin, so 100% container testing starts at raw material sampling.
For manufacturers: how these testing duties sit within Revised Schedule M is tracked on our CDSCO Schedule M compliance dashboard.
Trade enquiry: FTOX-AM Syrup
For licensed retailers, wholesalers and distributors. FTOX-AM is a Schedule H prescription medicine and is supplied to licensed trade buyers only. Call 98124 46733 or email contact@laafon.com.
Building a respiratory range? See our PCD pharma franchise and third-party manufacturing terms.
FTOX-AM syrup: frequently asked questions
No. Ambroxol + terbutaline + guaiphenesin + menthol is not on the 2018, 2023 or 2024 FDC prohibition lists. The similar five-ingredient syrup that adds ammonium chloride was prohibited in August 2024 under S.O. 3398(E); check any composition against the full list of 156 FDCs banned in 2024.
Yes. Terbutaline sulphate is a Schedule H drug, so FTOX-AM can be sold only on a registered medical practitioner’s prescription, in every state.
Not under 2 years, and it is not recommended under 6. From 6 to 11 years it should be used only as a doctor prescribes after examining the child, in line with the Health Ministry’s October 2025 advisory.
Product leaflets for this combination give 10 mL three times a day for adults and children aged 12 and over. Follow the prescription, and see the doctor again if the cough has not improved within 7 days.
No. Cough suppressants such as dextromethorphan, found in many dry cough syrups, stop the cough that clears the mucus ambroxol and guaiphenesin have loosened, so the two should not be combined.
Both pair a bronchodilator with ambroxol and guaiphenesin. FTOX-AM uses terbutaline and adds menthol; levosalbutamol syrups such as Cozicof-LS use levosalbutamol instead. The doctor chooses between them based on the patient.
FTOX-AM is marketed by Laafon Galaxy Pharmaceuticals and manufactured at a third-party WHO-GMP certified unit. The MRP is ₹92 for the 100 mL bottle.
References
- DrugBank Online. Ambroxol (DB06742). Available from: https://go.drugbank.com/drugs/DB06742. Accessed November 2026.
- MedlinePlus [Internet]. Bethesda (MD): National Library of Medicine (US); Terbutaline. Revised 15 May 2017. Available from: https://medlineplus.gov/druginfo/meds/a682144.html. Accessed November 2026.
- MedlinePlus [Internet]. Bethesda (MD): National Library of Medicine (US); Guaifenesin. Revised 15 January 2022. Available from: https://medlineplus.gov/druginfo/meds/a682494.html. Accessed November 2026.
- Xu L, Han Y, Chen X, Aierken A, Wen H, Zheng W, et al. Molecular mechanisms underlying menthol binding and activation of TRPM8 ion channel. Nat Commun. 2020;11(1):3790. doi:10.1038/s41467-020-17582-x. Available from: https://pubmed.ncbi.nlm.nih.gov/32728032/. Accessed November 2026.
- European Medicines Agency. Ambroxol and bromhexine expectorants: safety information to be updated with risk of allergy and skin reactions (EMA/130676/2015). London: EMA; 25 February 2015. Available from: https://www.ema.europa.eu/en/documents/press-release/ambroxol-and-bromhexine-expectorants-safety-information-be-updated-risk-allergy-and-skin-reactions-be-included-product-information_en.pdf. Accessed November 2026.
- Zuventus Healthcare Ltd. Soventus Syrup (ambroxol hydrochloride 20 mg, terbutaline sulphate 1.25 mg, guaifenesin 50 mg, menthol 0.5 mg per 5 mL): patient information leaflet. Revised October 2023. Available from: https://www.zuventus.com/sites/default/files/2024-09/Soventus-Syrup-PIL.pdf. Accessed November 2026.
- News On AIR (Prasar Bharati). Centre issues an advisory to States on use of cough syrups for children [Ministry of Health and Family Welfare advisory]. 3 October 2025. Available from: https://newsonair.gov.in/centre-issues-an-advisory-states-on-use-of-cough-syrups-for-children/. Accessed November 2026.
- Medical Dialogues. Health Ministry bans 328 FDC medicines: check out the complete list. 14 September 2018 (secondary compilation of the September 2018 prohibition notifications). Available from: https://business.medicaldialogues.in/health-minsitry-bans-328-fdc-banned-drugs-check-out-the-complete-list. Accessed November 2026.
- Indian Drug Manufacturers’ Association. IDMA Bulletin, 14 June 2023: Government prohibits 14 FDCs, S.O. 2394(E) to S.O. 2407(E) dated 02.06.2023. Mumbai: IDMA; 2023. Available from: https://idma-assn.org/assets/new-web/pdf/14_June_2023.pdf. Accessed November 2026.
- Ministry of Health and Family Welfare. Prohibition of 156 fixed dose combinations under section 26A of the Drugs and Cosmetics Act, 1940: S.O. 3285(E) to S.O. 3440(E). Gazette of India, Extraordinary, No. 3125, 12.08.2024 (first part of the series). Available from: https://egazette.gov.in/WriteReadData/2024/256531.pdf. Accessed November 2026.
- Central Drugs Standard Control Organisation. The Drugs Rules, 1945 and amending notifications, including G.S.R. 588(E) dated 30.08.2013 (Schedule H list). New Delhi: CDSCO. Available from: https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Drugs-Rules/. Accessed November 2026.
- Ministry of Health and Family Welfare. G.S.R. 477(E), Drugs (Fifth Amendment) Rules, 2026, dated 09.06.2026. Gazette of India, Extraordinary. Available from: https://egazette.gov.in/WriteReadData/2026/273467.pdf. Accessed November 2026.
- Central Drugs Standard Control Organisation. List of FDCs issued NOC, and FDCs permitted for continued manufacture under the 18-month policy (as on 04.04.2018). New Delhi: CDSCO; 2018. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalNewDrugs/April2018FinalRational.pdf. Accessed November 2026.
- Itagimatha N, Manjunatha DH. RP-HPLC-UV method development and validation for simultaneous determination of terbutaline sulphate, ambroxol HCl and guaifenesin in pure and dosage forms. Ann Pharm Fr. 2019;77(4):295-301. doi:10.1016/j.pharma.2019.02.004. Available from: https://pubmed.ncbi.nlm.nih.gov/31027752/. Accessed November 2026.
- Kantar A, Klimek L, Cazan D, Sperl A, Sent U, Mesquita M. An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children. Multidiscip Respir Med. 2020;15(1):511. doi:10.4081/mrm.2020.511. Available from: https://pubmed.ncbi.nlm.nih.gov/32269775/. Accessed November 2026.
- Cazan D, Klimek L, Sperl A, Plomer M, Kölsch S. Safety of ambroxol in the treatment of airway diseases in adult patients. Expert Opin Drug Saf. 2018;17(12):1211-1224. doi:10.1080/14740338.2018.1533954. Available from: https://pubmed.ncbi.nlm.nih.gov/30372367/. Accessed November 2026.
- World Health Organization. Medical Product Alert N°5/2025: Substandard (contaminated) oral liquid medicines. Geneva: WHO; 13 October 2025. Available from: https://www.who.int/news/item/13-10-2025-medical-product-alert-n-5-2025–substandard-(contaminated)-oral-liquid-medicines. Accessed November 2026.
- Medical Dialogues. After cough syrup deaths, CDSCO tightens oversight on drug testing compliance. 8 October 2025 (report of the DCGI communication to State and UT Drug Controllers). Available from: https://medicaldialogues.in/news/industry/pharma/cdsco/after-cough-syrup-deaths-cdsco-tightens-oversight-on-drug-testing-compliance-156572. Accessed November 2026.
Disclaimer: This page is product and educational information for healthcare professionals and licensed trade buyers. It is not medical advice and does not replace the prescription or the product label. FTOX-AM is a prescription medicine; use it only as a registered medical practitioner directs. Indian drug schedules and FDC rules change by gazette notification; the status above was checked on 2 November 2026.