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Caffeine: 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
59 entries containing Caffeine are on India's banned-drugs list, and 32 are banned today. 17 batches of medicines containing Caffeine failed a government lab test between March 2020 and May 2026, from 15 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Is it banned? Our answer pages
On the banned-drugs list
Caffeine 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 |
|---|---|---|---|---|---|
| Ergotamine Tartrate + Caffeine + Paracetamol + Prochlorperazine MaleateFixed-dose combination · painkillers | Banned | S.O. 3347(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Meclizine HCl + Paracetamol + CaffeineFixed-dose combination · painkillers | Banned | S.O. 3352(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Paracetamol + Diclofenac Potassium + Caffeine AnhydrousFixed-dose combination · painkillers | Banned | S.O. 3417(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Tramadol HCl + Paracetamol + Caffeine + TaurineFixed-dose combination · painkillers | Banned | S.O. 3440(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Atorvastatin + Acetyl Salicylic Acid + CaffeineFixed-dose combination · painkillers | Banned | S.O. 184(E) | 11 January 2019 | Other orders | 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 + Phenylephrine + Chlorpheniramine Maleate + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 254(E) | 11 January 2019 | Other orders | 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. |
| Paracetamol + Propyphenazone + CaffeineFixed-dose combination · painkillers | Under examination | S.O. 4689(E) | 7 September 2018 | 328 FDCs · Sep 2018 | SC order 14.02.2019: claimed pre-1988 FDC; under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 4#). Legally on sale pending examination. |
| Nimesulide + Cetirizine + CaffeineFixed-dose combination · painkillers | Banned | S.O. 4381(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Cetirizine + CaffeineFixed-dose combination · painkillers | Banned | S.O. 4383(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4395(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Domperidone + CaffeineFixed-dose combination · painkillers | Banned | S.O. 4410(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Disodium Hydrogen Citrate + CaffeineFixed-dose combination · painkillers | Banned | S.O. 4416(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Caffeine + Codeine PhosphateFixed-dose combination · painkillers | Banned | S.O. 4419(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4526(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Phenylephrine + Caffeine + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4527(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Loratadine + Dextromethorphan + Pseudoepheridine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4531(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chlorpheniramine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4539(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Acrivastine + Paracetamol + Caffeine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4576(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4579(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4588(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Levocetirizine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4590(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Paracetamol + Ambroxol + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4605(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Paracetamol + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4607(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Triprolidine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4610(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Caffeine + Paracetamol + Phenylephrine + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 4611(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Caffeine + Paracetamol + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4620(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Pseudoephedrine + Cetirizine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4626(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Paracetamol + Caffeine + NimesulideFixed-dose combination · painkillers | Banned | S.O. 4639(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chlorpheniramine + Paracetamol + Pseudoephedrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4653(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ergotamine Tartrate + Belladonna Dry Extract + Caffeine + ParacetamolFixed-dose combination · painkillers | Banned | S.O. 4681(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4700(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Cetirizine + CaffeineFixed-dose combination · painkillers | Quashed | S.O. 707(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Cetirizine + CaffeineFixed-dose combination · painkillers | Quashed | S.O. 709(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Phenylephrine + CaffeineFixed-dose combination · painkillers | Under examination | S.O. 713(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). |
| Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 723(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Domperidone + CaffeineFixed-dose combination · painkillers | Quashed | S.O. 739(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Disodium Hydrogen Citrate + CaffeineFixed-dose combination · painkillers | Quashed | S.O. 746(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Caffeine + Codeine PhosphateFixed-dose combination · painkillers | Quashed | S.O. 749(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 863(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Loratadine + Dextromethorphan + Pseudoepheridine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 868(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Acrivastine + Paracetamol + Caffeine + PhenylephrineFixed-dose combination · cough-cold | Quashed | S.O. 915(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 918(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 929(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Phenylephrine + Levocetirizine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 932(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Phenylephrine + Paracetamol + Ambroxol + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 947(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levocetirizine + Paracetamol + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 949(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Caffeine + Paracetamol + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Under examination | S.O. 950(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). |
| Paracetamol + Phenylephrine + Triprolidine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 953(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Caffeine + Paracetamol + Phenylephrine + CetirizineFixed-dose combination · cough-cold | Quashed | S.O. 954(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Caffeine + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Quashed | S.O. 959(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Caffeine + Paracetamol + ChlorpheniramineFixed-dose combination · cough-cold | Quashed | S.O. 963(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Pseudoephedrine + Cetirizine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 969(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Phenylephrine + Paracetamol + Caffeine + NimesulideFixed-dose combination · painkillers | Quashed | S.O. 985(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Chlorpheniramine + Paracetamol + Pseudoephedrine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 999(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ergotamine Tartrate + Belladonna Dry Extract + Caffeine + ParacetamolFixed-dose combination · painkillers | Quashed | S.O. 1027(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Propyphenazone + CaffeineFixed-dose combination · painkillers | Quashed | S.O. 1036(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 1047(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Crude Ergot Preparations except Those containing Ergotamine, Caffeine, Analgesics, Antihistamines for the Treatment of Migraine, HeadachesFixed-dose combination · painkillers | Banned | GSR 304(E) | 7 June 1991 | Classic bans | Entry text as substituted vide GSR 304(E) dated 1991-06-07; original 1983/1988 notification superseded. |
| Strychnine and Caffeine in TonicsFixed-dose combination · vitamins | Banned | GSR 578(E) | 23 July 1983 | Classic bans | In force per CDSCO consumer list (1983-2017) |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Paracetamol Caffeine | 2 | 2 | May 2026 |
| Paracetamol Phenylephrine Hydrochloride Caffeine Diphenhydramine | 2 | 2 | Sep 2025 |
| Aceclofenac Paracetamol Phenylephrine Hcl Cetirizine Caffeine | 1 | 1 | May 2026 |
| Paracetamol Phenylephrine Hcl Caffeine Disphenhydramine | 1 | 1 | May 2026 |
| Paracetamol Chlorpheniramine Maleate Caffeine Phenylephrine Hydrochloride | 1 | 1 | Feb 2026 |
| Paracetamol Phenylephrine Hydrochloride Diphenhydramine Hydrocloride Caffeine | 1 | 1 | Feb 2026 |
| New Unsyn Acetyl Salicyclic Acid Paracetamol Caffeine | 1 | 1 | Dec 2025 |
| Paracetamol Phenylphrine Hcl Cpm Caffeine | 1 | 1 | Jun 2025 |
| Paracetamo L Phenylephri Ne Hcl Caffeine Diphenhydr Amine | 1 | 1 | Jan 2025 |
| Caffeine Anhydrous | 1 | 1 | Nov 2023 |
| Caffeine Citrate / | 1 | 1 | Sep 2023 |
| Paracetamol Phenylphrine Hydrochloride Diphenhydramine Caffeine | 1 | 1 | May 2023 |
| Pcd Cold | 1 | 1 | Nov 2022 |
| Snezee Paracetamol Phenylephrine Hci Caffeine Diphenhydramine | 1 | 1 | Mar 2022 |
| Paracetamol Propyphenazone Caffeine | 1 | 1 | Mar 2020 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Paracetamol, Phenylephrine HCL, Caffeine and Disphenhydramine HCL Tablets | UT-250656DMfg 2025-05 · Exp 2027-04 | Ultra Drugs Pvt. Ltd. (Unit-II) HS No. 211Himachal Pradesh | The sample fails in the Test for Description and DisintegrationDescription | MDTL KathuaState lab | May 2026 |
| Paracetamol & Caffeine Tablets IP | HRA25001Mfg 2025-04 · Exp 2027-03 | Danish Healthcare (P) Ltd. 76/26-2B | Assay and DissolutionAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Aceclofenac, Paracetamol, Phenylephrine Hcl Cetirizine Hcl & Caffeine | GT-25294AMfg 2025-08 · Exp 2028-07 | Not applicable | MisbrandadMisbranded | SDTL, ChhattisgarhState lab | May 2026 |
| Paracetamol, Phenylephrine Hydrochloride Diphenhydramine, Hydrocloride & Caffeine Tablets | YLT25023Mfg 2025-06 · Exp 2027-05 | YL PharmaHimachal Pradesh | The sample does not conform to the claim with respect to in Assay of Phenylephrine Hydrochloride & Caffeine (Anhydrous) (NIL).Assay | DTL JaipurState lab | Feb 2026 |
| Paracetamol, Chlorpheniramine Maleate, Caffeine and Phenylephrine Hydrochloride Tablets | MAAI20724Mfg 2024-07 · Exp 2027-06 | Suraksha Pharma Pvt. LtdUttarakhand | Test for Disintegration onlyDisintegration | RDTL, Hubli, KarnatakaState lab | Feb 2026 |
| Paracetamol and Caffeine Tablets IP | APSDN 2506Mfg 2025-04 · Exp 2027-03 | Konis Pharmaceuticals Pv t. LtdHimachal Pradesh | DescriptionDescription | DTL, Madurai-19State lab | Feb 2026 |
| New unsyn Tablets Acetyl Salicyclic Acid BP 150mg Paracetamol BP 150mg, Caffeine (Anhydrous) BP 25mg Tablets | 63Mfg 2023-08 · Exp 2026-07 | National Pharmacetutical G-18/1Maharashtra | DescriptionDescription | FDAL, MumbaiState lab | Dec 2025 |
| Paracetamol, Phenylephrine Hcl, Caffeine & Diphenhydramine Hcl Tablets | YLT25006Mfg 2025-01 · Exp 2026-12 | YL PharmaHimachal Pradesh | Identification & AssayAssay | DTL ,Baddi, HPState lab | Sep 2025 |
| Paracetamol, Phenylphrine HCL, CPM & Caffeine Tablets (Goco-Plus) | DPT-1223Mfg 2024-09 · Exp 2026-08 | Dexibo Pharma Pvt. LtdUttarakhand | DisintegrationDisintegration | State Lab PuducherryState lab | Jun 2025 |
| Paracetamo l, Phenylephri ne HCl, Caffeine & Diphenhydr amine HCl Tablets (CINKOLD) | SG034B0 3Mfg 2023-02 · Exp 2025-01 | Sharun Pharmaceuticals Pvt.LtdPuducherry | NOTE:(i) On the received sample, Presence of Spot defect was observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. vel - NSQLabelling | State Lab PuducherryState lab | Jan 2025 |
| Caffeine Anhydrous BP | CF/23/0007Mfg 2023-07 · Exp 2028-06 | Bakul Aromatics and Chemicals Pvt. Ltd | Spurious with respect to the Identification test for caffeineIdentification | CDTL MumbaiCDSCO lab | Nov 2023 |
| Caffeine Citrate Injection USP 60mg/3ml | I-5735Mfg 2022-12 · Exp 2024-11 | Jakson Laboratories Pvt. LtdPunjab | Sterility & Bacterial EndotoxinsSterility | CDL KolkataCDSCO lab | Sep 2023 |
| Paracetamol, Phenylphrine Hydrochloride, Diphenhydramine Hydrochloride and Caffeine Tablets (Syscold Tablets) | SPT?192Mfg 2022-01 · Exp 2023-12 | Signoret Pharmaceuticals Pvt.LtdPunjab | Disintegration test and Assay of Phenylephrine HydrochlorideAssay | RDTL ChandigarhState lab | May 2023 |
| PCD COLD� (Paracetamol, Phenylephrine HCl, Caffeine & Diphenhydramine HCl Tablets) | GLT-21213Mfg 2021-03 · Exp 2024-02 | Gopal LifesciencesHimachal Pradesh | DisintegrationDisintegration | RDTL GuwahatiState lab | Nov 2022 |
| Paracetamol, Phenylephrine Hydrochloride, Caffeine and Diphenhydramine Hydrochloride (SNEZEE 500) | TP1020810Mfg 2020-10 · Exp 2022-09 | Maxrelief HealthcareHimachal Pradesh | Identification and AssayAssay | RDTL GuwahatiState lab | Apr 2022 |
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.