Ingredient record · Cough expectorant
Guaifenesin: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
79 entries containing Guaifenesin are on India's banned-drugs list, and 42 are banned today. 168 batches of medicines containing Guaifenesin failed a government lab test between January 2019 and July 2026, from 133 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
42
Banned combinations in force
37
Other listed orders (stayed, restricted, quashed)
168
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned (LS/D) · old formulas banned
Not banned · two combos banned (2024)
On the banned-drugs list
Guaifenesin on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Ambroxol HCl + Phenylephrine HCl + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 3394(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ambroxol HCl + Terbutaline Sulphate + Ammonium Chloride + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 3398(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ambroxol HCl + Salbutamol Sulphate + Ammonium Chloride + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 3399(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 3400(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Salbutamol Sulphate + Bromhexine HCl + Guaifenesin + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Banned | S.O. 3402(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Chlorpheniramine Maleate + Dextromethorphan + Guaifenesin + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Banned | S.O. 2397(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Dextromethorphan + Chlorpheniramine + Guaifenesin + Ammonium ChlorideFixed-dose combination · cough-cold | Banned | S.O. 2401(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 2402(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Dextromethorphan + Bromhexine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4525(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + MentholFixed-dose combination · cough-cold | Banned | S.O. 4534(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethophen + Bromhexine + Chlorpheniramine Maleate + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4535(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Ambroxol + Phenylephrine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4536(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4538(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Phenylephrine + Ambroxol + Guaifenesin + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 4548(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diphenhydramine + Guaifenesin + Ammonium Chloride + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 4551(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diethylcabamazine Citrate + Cetirizine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4554(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Chlorpheniramine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4558(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Terbutaline + Bromhexine + Guaifenesin + DextromethorphanFixed-dose combination · cough-cold | Banned | S.O. 4559(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4564(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Banned | S.O. 4570(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4575(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Terbutaline + Ambroxol + Guaifenesin + Zinc + MentholFixed-dose combination · cough-cold | Banned | S.O. 4580(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Guaifenesin + TriprolidineFixed-dose combination · cough-cold | Banned | S.O. 4582(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4586(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Salbutamol + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4593(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Dextromethorphan + Bromhexine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4595(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diethylcarbamazine + Chlorpheniramine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4596(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol (Acetaminophen) + Guaifenesin + Dextromethorphan + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4603(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Guaifenesin + DextromethorphanFixed-dose combination · cough-cold | Banned | S.O. 4606(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4612(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Levocetirizine + Phenylephrine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4613(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Salbutamol + Aminophylline + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4617(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chlorpheniramine + Dextromethorphan + Guaifenesin + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4619(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4631(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Guaifenesin + Cetirizine + Paracetamol (Acetaminophen)Fixed-dose combination · cough-cold | Banned | S.O. 4634(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Guaifenesin + Bromhexine + Chlorpheniramine + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 4635(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Cetirizine + Guaifenesin + Ammonium ChlorideFixed-dose combination · cough-cold | Banned | S.O. 4640(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4642(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Bromhexine + Cetirizine + Phenylephrine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4644(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Terbutaline + N-Acetylcysteine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4647(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase (as Enteric Coated Granules) 10000 S P UnitsFixed-dose combination · cough-cold | Banned | S.O. 4654(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Guaifenesin + Diphenhydramine + Bromhexine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4690(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Bromhexine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 862(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Chlorpheniramine Maleate + Dextromethorphan + Dextromethorphan + Guaifenesin + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Under examination | S.O. 869(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + MentholFixed-dose combination · cough-cold | Quashed | S.O. 872(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethophen + Bromhexine + Chlorpheniramine Maleate + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 873(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Ambroxol + Phenylephrine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 874(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + MentholFixed-dose combination · cough-cold | Quashed | S.O. 876(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Phenylephrine + Ambroxol + Guaifenesin + ParacetamolFixed-dose combination · cough-cold | Quashed | S.O. 886(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Diphenhydamine + Guaifenesin + Ammonium Chloride + BromhexineFixed-dose combination · cough-cold | Quashed | S.O. 889(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Diethylcabamazine + Cetirizine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 892(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Chlorpheniramine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 896(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Terbutaline + Bromhexine + Guaifenesin + DextromethorphanFixed-dose combination · cough-cold | Quashed | S.O. 897(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Quashed | S.O. 902(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Quashed | S.O. 908(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Quashed | S.O. 914(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Terbutaline + Ambroxol + Guaifenesin + Zinc + MentholFixed-dose combination · cough-cold | Quashed | S.O. 919(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Phenylephrine + Guaifenesin + TriprolidineFixed-dose combination · cough-cold | Quashed | S.O. 921(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Quashed | S.O. 927(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Chlorpheniramine + Guaifenesin + Ammonium ChlorideFixed-dose combination · cough-cold | Under examination | S.O. 930(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
Showing the 60 most recent of 79. The full list and CSV have the rest.
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
Top 30 of 69 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Paracetamol, Phenylephrine HCL, Guaiphenesin, Cetirizine Hydrochloride & Ambroxol HCL Tablets | SBT-3351Mfg 2025-07 · Exp 2027-06 | Supercure Biotech Pvt. LtdHaryana | The sample is found to be Not of Standard Quality for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jul 2026 |
| Celltus-B (Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup) | CLAM-2525Mfg 2025-12 · Exp 2027-11 | Comex Pharma | 01. ASSAY OF TERBUTALINE SULPHATE I.P. ?Less than prescribed limit.Assay | SFDTL UttarakhandState lab | Jul 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | BGL250945Mfg 2025-09 · Exp 2027-08 | Bestcare Formulation PvtPuducherry | Content of Ambroxol Hydrochloride(75.7%) and Terbutaline Sulphate (85.6%)Other | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Terbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesin & Menthol Syrup | EM1LF005Mfg 2025-04 · Exp 2027-03 | Unicure India LtdUttarakhand | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Terbutaline Sulphate, Bromhexine HCl, Guaiphenesin & Menthol Syrup | M24317Mfg 2024-12 · Exp 2026-11 | Healcure LifesciencesHimachal Pradesh | Assay for Bromhexine Hydrochloride and Description as per Schedule V of Drugs and Cosmetics Act 1940 & Rules 1945 thereunderAssay | DTL, Bengaluru, KarnatakaState lab | Jun 2026 |
| Terbutaline Sulphate, Ambroxol Hydrochloride, Guaiphenesin & Menthol Expectorant | JLI2586Mfg 2025-09 · Exp 2027-08 | Janveda Healthceutical Pvt. LtdGujarat | Ambroxol Hydrochloride contentOther | FDL, VadodaraState lab | Jun 2026 |
| Levosalbutamol Sulphate, Ambroxol HCl & Guaiphenesin Syrup 60 ml | SD-1376CMfg 2025-07 · Exp 2027-06 | Sano-Cito Therapeutics IncHimachal Pradesh | The sample does not conform to claim as per Schedule V of Drugs and Cosmetic Acts and Rules 1945 with respect to Assay/content of Levosalbutamol sulphate Equivalent to Levosalbutamol.Assay | CDL KolkataCDSCO lab | Jun 2026 |
| Levosalbutamol Sulphate Ambroxol Hydrochloride and Guaiphenesin Expectorant. | 18253692AMfg 2025-09 · Exp 2027-08 | Macleods Pharmaceuticals LtdSikkim | Description as per Schedule V of Drugs and Cosmetics act 1940 & Rules 1945 thereunder.Description | DTL, Bengaluru, KarnatakaState lab | Jun 2026 |
| Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | L-2601029Mfg 2026-01 · Exp 2027-12 | Rivpra Formulation Pvt. LtdUttarakhand | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Bromhexine Hydrochloride.Assay | RDTL, ChandigarhCDSCO lab | Jun 2026 |
| Ambroxol Hydrochloride, Terbutaline, Guaiphenesin & Menthol Syrup | KL08501Mfg 2025-03 · Exp 2027-02 | Kinesis Laboratories Pvt.LtdHimachal Pradesh | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Ambroxol Hydrochloride Terbutaline Sulphate Guaiphenesin & Menthol Syrup | RG-043Mfg 2025-08 · Exp 2027-07 | Redner FormulationsPuducherry | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Terbutaline Sulphate, Bromhexine Hydrochloride Guaiphenesin & Menthol Syrup | ULD014Mfg 2025-04 · Exp 2027-03 | Haustus Biotech Pvt. Ltd. 44-45 | AssayAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Terbutaline Sulphate, Bromhexine HCL, Guaiphenesin & Menthol Syrup | AL25061Mfg 2025-06 · Exp 2027-05 | Cian Healthcare LtdUttarakhand | ContentOther | DTL, Chennai-06State lab | May 2026 |
| Terbutaline Sulphate, Ambroxol Hydrochloride, Guaiphenesin and Menthol Syrup | SPL-1934Mfg 2025-11 · Exp 2027-10 | Sheen Pharmaceuticals Wariana Industrial Complex Jal. P.b. 144021 | The Sample does not confirm to claim as Patient & Propritary in respect to the Assay of MentholAssay | DTL , BaddiState lab | May 2026 |
| Ambroxol, Terbutaline Guaiphenesin with Menthol Syrup | AL24-0611AMfg 2024-12 · Exp 2026-11 | Aspo Pharmaceuticals LLPHimachal Pradesh | The sample does not conform to Manufacturer's Specification with respect to Assay of Ambroxol Hydrochloride, Guaiphenesin, and Terbutaline SulphateAssay | CDL, KolkataCDSCO lab | May 2026 |
Showing 15 of 168 records
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