Ingredient record · Cough expectorant
Guaifenesin: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
79 entries containing Guaifenesin are on India's banned-drugs list, and 42 are banned today. 182 batches of medicines containing Guaifenesin failed a government lab test between January 2019 and September 2026, from 141 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)
182
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned (LS/D) · old formulas banned
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 73 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Levosalbutamol, Guaiphenesin & Ambroxol Hydrochloride syrup | Batch UFL251248KMfg Dec 2025 · Exp Nov 2027 | Ultra Drugs Formulations Pvt LtdHimachal Pradesh | content- Ambroxol HydrochlorideOther | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Levosalbutamol, Ambroxol Hydrochloride & Guaiphenesin Syrup | Batch TS-399Mfg Aug 2025 · Exp Jul 2027 | Trimedix Pharma (P) LtdPunjab | TESTS FOR ASSAY (CONTENT) OF AMBROXOL HYDROCHLORIDEAssay | DTL, DelhiState lab | Sep 2026 |
| Levosalbutamol Sulphate, Ambroxol Hydrochloride and Guaiphenesin Syrup | Batch AGL51232Mfg Dec 2025 · Exp Nov 2027 | Alventa Pharma LtdHimachal Pradesh | content - Levosalbutamol(in Levosalbutamol Sulphate) and Ambroxol HydrochlorideOther | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | Batch L-2507011Mfg Jul 2025 · Exp Jun 2027 | Rivpra Formulation Pvt. LtdUttarakhand | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Bromhexine Hydrochloride, Terbutaline SulphateAssay | RDTL, ChandigarhCDSCO lab | Sep 2026 |
| Ambroxol, Terbutaline & Guaiphenesin Cough Expectorant | Batch GRL600425Mfg Apr 2025 · Exp Mar 2027 | Guinness Remedies Pvt. Ltd | The sample does not conform to declared formula with respect to Identity test for Ambroxol Hydrochloride." Sample gives negative identity test for Diethylene Glycol (DEG) & Ethylene Glycol (EG).Other | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | Batch L15017AMfg Sep 2025 · Exp Aug 2027 | Navkar LifesciencesHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Sep 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate & Guaiphenesin Syrup | Batch T3-13Mfg Apr 2025 · Exp Mar 2027 | Swiss India LaboratoriesHimachal Pradesh | TESTS FOR ASSAY (CONTENT) OF AMBROXOL HYDROCHLORIDEAssay | DTL, DelhiState lab | Sep 2026 |
| Levosalbutamol, Ambroxol Hydrochloride, Guaiphenesin & Menthol Syrup | Batch BL25-049AMfg May 2025 · Exp Apr 2027 | Biocore PharmaceuticalsHimachal Pradesh | Content - Levosalbutamol in Levosalbutamol Sulphate and Ambroxol HydrochlorideOther | DTL, Chennai-06State lab | Aug 2026 |
| Levosalbutamol Sulphate, Ambroxol Hydrochloride Guaiphenesin Syrup | Batch NBVL-07Mfg Aug 2025 · Exp Jul 2027 | Ntk PharmaaTamil Nadu | Content - Levosalbutamol in Levosalbutamol SulphateOther | DTL, Chennai-06State lab | Aug 2026 |
| Guaiphenesin, Ambroxol Hydrochloride, Menthol and Terbutline Sulphate Syrup | Batch L260424Mfg Apr 2026 · Exp Mar 2028 | SGS Formulation Pvt LtdTamil Nadu | Content of Ambroxol Hydrochloride and Terbutline SulphateOther | DTL, Madurai-19State lab | Aug 2026 |
| Bromhexine, Terbutaline and Guaiphenesin Mentholated Syrup | Batch SL254444Mfg Feb 2026 · Exp Jan 2028 | Star Filteration SystemsHimachal Pradesh | Content - Terbutaline SulphateOther | DTL, Chennai-06State lab | Aug 2026 |
| Ambroxol Hydrochloride, levosalbutamol sulphate and Guaiphenesin Syrup | Batch BL-299Mfg Feb 2026 · Exp Jan 2028 | Bonn Stering Bio Science LLPPuducherry | Content - Ambroxol HydrochlorideOther | DTL, Chennai-06State lab | Aug 2026 |
| Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin and menthol syrup | Batch AMS26D059Mfg Mar 2026 · Exp Feb 2028 | Alop Medi-Sciences Pvt. LtdHimachal Pradesh | Content of Terbutaline SulphateOther | DTL, Chennai-06State lab | Aug 2026 |
| Ambroxol Hcl, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup I.P. | Batch LXR25-1Mfg May 2025 · Exp Apr 2027 | Leostar Healthcare Pvt. LtdTelangana | Sample Does not comply Description, Assay for Ambroxol HydrochlorideAssay | State Lab, DCL, TelanganaState lab | Aug 2026 |
| Paracetamol, Phenylephrine HCL, Guaiphenesin, Cetirizine Hydrochloride & Ambroxol HCL Tablets | Batch SBT-3351Mfg Jul 2025 · Exp Jun 2027 | 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 |
Showing 15 of 182 records
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