Class 4 Medicines Defect Information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) (McNeil Products Limited)
Class 4 Medicines Defect Information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) (McNeil Products Limited)
Drug alert number: EL (21)A/39
Date issued: 21 December 2021
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:
Class 4 Medicines Defect Information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) (McNeil Products Limited)
McNeil Products Limited have identified an error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL) whereby the product labels understate the ethanol values. The products comply with the defined specifications, including ethanol content and, other than the incorrect ethanol content, all other label information is correct. However, the amount of ethanol contained within the products is low and hence the related on-pack safety warning, which reads “The small amount of alcohol in this medicine will not have any noticeable effects.”, is correct.
A table of the current (incorrect) and required (correct) labelling text can be seen below:
| Products | Licences | Current labelling text (incorrect) | Required labelling text (correct) |
| Benylin Chesty Coughs Original (P) | PL 15513/0048 | This medicine contains 0.26 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. | This medicine contains 197 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. |
| Benylin Chesty Coughs Non-Drowsy (GSL) | PL 15513/0056 | This medicine contains 0.7 mg of alcohol (ethanol) in each 5 ml dose. The amount in a 5 ml dose of this medicine is equivalent to less than 1 ml beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects. | This medicine contains 197 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. |
Affected batches
Benylin Chesty Coughs Original (P)
| Batch Number | Expiry Date | Pack Size | First Distributed |
| V3879R | 10/2023 | 300ml | Not distributed yet |
| V3880R | 10/2023 | 300ml | Not distributed yet |
| V4017R | 10/2023 | 300ml | Not distributed yet |
| V4011R | 10/2023 | 150ml | Not distributed yet |
| V4016R | 10/2023 | 150ml | Not distributed yet |
Active Pharmaceutical Ingredient: Diphenhydramine hydrochloride, Levomenthol
Benylin Chesty Coughs Non-drowsy (GSL)
| Batch Number | Expiry Date | Pack Size | First Distributed |
| V3366R | 08/2024 | 300ml | 03-Nov-2021 |
| V3367R | 09/2024 | 150ml | Not distributed yet |
| V3371R | 08/2024 | 150ml | Not distributed yet |
| V3260R | 09/2024 | 150ml | Not distributed yet |
| V3621R | 09/2024 | 150ml | Not distributed yet |
| V3993R | 10/2024 | 150ml | Not distributed yet |
Active Pharmaceutical Ingredient: Guaifenesin, Levomenthol
Advice for healthcare professionals
The impacted products are within specification and there is no issue with product quality. Despite the label error understating the ethanol content, the related label warning is correct. Therefore, the affected batches are not being recalled. Due to the products complying with the specifications, including ethanol content within the product, the batches on hold awaiting distribution will continue to be sold and have been included in this notification for information.
Since the products are within specification, there are no quality issues with the products and all safety warnings including the warning related to the alcohol content are correct, no specific action is required by healthcare professionals or retailers and this notification is being shared for information.
View full alert here
Further Information
For medical information queries please contact: McNeil Products Limited on 01344 864042 or by email to crc@its.jnj.com.
