Regulatory status record
Which cetirizine combinations are banned in India?
Last checked 3 November 2026
Cetirizine on its own is not banned in India; 39 combinations containing it are prohibited, including cetirizine + paracetamol + phenylephrine (S.O. 3385(E)) and cetirizine + phenylephrine (S.O. 3386(E)) of 2 Aug 2024 and 35 from the 7 Sep 2018 wave.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for cetirizine alone; S.O. 3385(E), 3386(E) and 3400(E), 2 Aug 2024; 35 entries of 7 Sep 2018; S.O. 256(E), 11 Jan 2019
- Evidence
- Government document
- Latest action
- 2 August 2024
- Last checked
- 3 November 2026
Cetirizine tablets in a blister pack. Photo: Cetirizine tablets under the brand name «Зодак».jpg by Issuial (CC0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
CDSCO: Updated banned drugs list with present status (as on 22.11.2021)
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.
Key facts
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Cetirizine alone
- Not banned; on the National List of Essential Medicines
- Banned 2 Aug 2024
- Cetirizine + paracetamol + phenylephrine, S.O. 3385(E) (Cheston Cold type); cetirizine + phenylephrine, S.O. 3386(E); cetirizine + terbutaline + ambroxol + guaifenesin, S.O. 3400(E)
- Banned 7 Sep 2018
- 35 cetirizine combinations, for example paracetamol + cetirizine + caffeine (S.O. 4383(E)), pseudoephedrine + cetirizine (S.O. 4614(E)), dextromethorphan + cetirizine (S.O. 4578(E))
- Banned 11 Jan 2019
- Nimesulide + pseudoephedrine + cetirizine, S.O. 256(E)
- Levocetirizine
- Also legal alone; its own combinations, such as levocetirizine + phenylephrine (S.O. 3387(E), 2024), are banned separately
Where the claim comes from
The August 2024 ban list included cetirizine + paracetamol + phenylephrine, the formula behind Cheston Cold and many generic cold tablets, plus cetirizine + phenylephrine and a four-drug cetirizine cough syrup. News lists showed 'cetirizine' in bold, and the single-ingredient antihistamine was assumed to be included.
Cetirizine is the most widely used antihistamine in India, sold under brands such as Cetzine, Okacet and Zyrtec. On its own it is not banned. This page lists the cetirizine combinations that are.
The best known is cetirizine + paracetamol + phenylephrine, the Cheston Cold formula, prohibited on 2 August 2024 under S.O. 3385(E). The same notification set banned cetirizine + phenylephrine (S.O. 3386(E)) and cetirizine + terbutaline + ambroxol + guaifenesin (S.O. 3400(E)). In each case the expert committee found no therapeutic justification for the fixed combination, the standard test under Section 26A.
Most cetirizine bans are older. The 7 September 2018 wave prohibited 35 combinations containing cetirizine, mostly cough and cold mixtures that add paracetamol, caffeine, pseudoephedrine, dextromethorphan, phenylephrine or nimesulide. Nimesulide + pseudoephedrine + cetirizine followed on 11 January 2019 under S.O. 256(E). Levocetirizine, the single-isomer version, has its own list of banned combinations, including levocetirizine + phenylephrine (S.O. 3387(E)) of 2024.
For allergy sufferers nothing has changed. For anyone using a "cold and flu" tablet, the ingredient list is what matters: if cetirizine shares the tablet with paracetamol and phenylephrine, or with phenylephrine alone, it is a prohibited product.
What this means for you
Plain cetirizine is unaffected
Tablets and syrup with cetirizine as the only active ingredient remain licensed.
Cold tablets with cetirizine need a check
If the pack also lists paracetamol and phenylephrine, or phenylephrine alone, it is a banned combination.
Read every ingredient
Most banned cetirizine products are cough and cold mixes with three to six ingredients. The full list is in the 2018 and 2024 ban pages.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Which cetirizine combinations are banned in India?
39 are prohibited, including cetirizine + paracetamol + phenylephrine and cetirizine + phenylephrine (2 Aug 2024) and 35 from 7 Sep 2018.
Is cetirizine banned in India?
No. Cetirizine on its own is legal; only specific combinations containing it are banned.
Is the Cheston Cold combination banned?
Yes. Cetirizine + paracetamol + phenylephrine has been prohibited since 2 Aug 2024 under S.O. 3385(E).
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Cetirizine HCl + Paracetamol + Phenylephrine HCl | Banned | S.O. 3385(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Phenylephrine HCl | Banned | S.O. 3386(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine + Phenylephrine HCl | Banned | S.O. 3387(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine + Phenylephrine HCl + Paracetamol | Banned | S.O. 3388(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Phenylephrine HCl + Paracetamol + Levocetirizine HCl + Menthol | Banned | S.O. 3389(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine HCl + Ambroxol HCl + Paracetamol | Banned | S.O. 3390(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine HCl + Ambroxol HCl + Phenylephrine HCl | Banned | S.O. 3391(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Diethylcarbamazine Citrate + Levocetirizine HCl | Banned | S.O. 3393(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + Guaifenesin | Banned | S.O. 3400(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Nimesulide + Pseudoephedrine + Cetirizine | Banned | S.O. 256(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Cetirizine + Caffeine | Banned | S.O. 4381(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Cetirizine + Caffeine | Banned | S.O. 4383(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
Ingredient records
Every banned combination and failed batch containing each ingredient.
Batches declared Not of Standard Quality
Batches of products containing Cetirizine flagged in CDSCO monthly alerts. An NSQ result concerns one batch, not the molecule or the brand.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP | Batch FMT26015SLMfg Apr 2026 · Exp Mar 2028 | Shiva Biogenetic Laboratories Pvt. LtdHimachal Pradesh | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Montelukast Sodium and Levocetirizine Hydrochloride Tablets | Batch ZDTY030Mfg Dec 2025 · Exp Nov 2027 | Pro-pharma Care Pvt. LtdUttarakhand | The sample dose not conform to I.P., in respect of Uniformity of content and DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP | Batch T260356KMfg Mar 2026 · Exp Feb 2028 | Unispeed Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Montelukast Sodium & Levcocetirizine Hydrochloride Tablets IP | Batch D25M01MEMfg Dec 2025 · Exp Nov 2027 | Mapra Laboratories Pvt. LtdDaman & Diu | The sample does not conform to IP with respect to the DissolutionDissolution | SDTL, GuwahatiState lab | Sep 2026 |
| Levocetirizine Tablets IP 5mg | Batch 0726A021Mfg Jan 2026 · Exp Dec 2027 | FDC LimitedGoa | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Levocetirizine Hydrochloride, Ambroxol Hydrochlolride | Batch 26LK024Mfg Jan 2026 · Exp Jan 2028 | Kantil Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not comply with the prescribed requirement for 'Description'Description | DTL, Dalgate Srinagar KashmirState lab | Sep 2026 |
| Levocetirizine Hydrochloride & Montelukast Sodium tablets IP | Batch UGT-25627LMfg May 2025 · Exp Apr 2027 | Ultra Drugs Pvt. LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Sep 2026 |
| Levocetirizine Dihydrochloride 5mg Tablets IP | Batch MPR-251105Mfg Nov 2025 · Exp Oct 2027 | Preet Remedies LtdHimachal Pradesh | The sample is not of standard quality for the reason stated under "Description" of the tablets.Description | RDTL, GuwahatiCDSCO lab | Sep 2026 |
| Levocetirizine Dihydrochloride & Montelukast Tablets IP | Batch LGP12/303/37Mfg Dec 2025 · Exp Nov 2027 | Logos PharmaHimachal Pradesh | The sample does not conform to IP with respect to the DissolutionDissolution | SDTL, GuwahatiState lab | Sep 2026 |
| Cetirizine Hydrocloride and Ambroxol Hydrochloride Syrup | Batch P0126002LMfg Jan 2026 · Exp Dec 2027 | Pharma Roots HealthcareHimachal Pradesh | content - Ambroxol HydrochlorideOther | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Montelukast sodium & Levocetirizine hydrochloride Tablets IP | Batch VRNT-933Mfg Mar 2025 · Exp Feb 2027 | Vrihaan Pharmaceuticals LLP | DissolutionDissolution | FDL, VadodaraState lab | Aug 2026 |
| Montelukast Sodium & Levocetirizine Hydrochloride Suspension | Batch DL508027Mfg Aug 2025 · Exp Jul 2027 | Renowed Life SciencesUttarakhand | Assay of Levocetirizine Hydrochloride.Assay | SFDTL, UttarakhandState lab | Aug 2026 |
| Montelukast & Levocetirizine Hydrochloride Syrup | Batch PTKLA004Mfg Nov 2025 · Exp Oct 2027 | Laborate Pharmaceuticals India Ltd (Unit-ii) 31Himachal Pradesh | Assay of Levocetirizine HydrochlorideAssay | SFDTL, UttarakhandState lab | Aug 2026 |
| Levocetirizine Hydrochloride and Montelukast Tablets | Batch 41046Mfg Nov 2025 · Exp Oct 2027 | Ronak Life Care Pvt. Ltd | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Montelukast.Dissolution | RDTL, GuwahatiCDSCO lab | Aug 2026 |
| Levocetirizine Dihydrochloride,Montelukast Soidum & Ambroxol (SR) | Batch ITH002Mfg Aug 2025 · Exp Jul 2027 | Cis Life Care Pvt.Ltd.44-45 | The sample does not confom to IP 2022 requirements with respect to Uniformity of weightUniformity of weight/content | DTL,Dalgated Srinagar KashmirState lab | Aug 2026 |
Sources
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- CDSCO: Updated banned drugs list with present status (as on 22.11.2021)RegulatorCDSCO · 22 November 2021
- Goa DFDA circular: 156 FDCs banned (copy of Gazette list)RegulatorDirectorate of Food and Drugs Administration, Goa · 22 August 2024