Chandigarh, Oct. 9 -- The Haryana Food and Drugs Administration (FDA) have issued show cause notices to four pharmaceutical companies for misbranding cough-cold syrups containing phenylephrine hydrochloride and chlorpheniramine maleate, thus contravening provisions of Drugs and Cosmetics Act. While the Union health ministry had in April 2025 restricted the manufacture, sale or distribution of all formulations of fixed dose combination (FDC) of chlorpheniramine maleate and phenylephrine hydrochloride subject to condition that the manufacturers will mention the warning "fixed dose combination shall not be used in children below four years of age" on the label and package insert or the promotional literature of the drug, the cough cold syrups manufactured by four companies did not carry the warning, FDA officials said The show cause notices were issued on October 7 to three Himachal Pradesh based pharmaceutical companies - M/s Leeford Healthcare Ltd which manufactures Criticold syrup, M/s Comed Chemicals Ltd which manufactures Medler AF syrup and M/s Wallace Pharmaceuticals Ltd which manufactures Flucold AF syrup. The fourth company is Madhya Pradesh based IPCA Laboratories which manufactures Solvin Cold AF Syrup. Issued by FDA's Drugs Control officer, Gurugram, Amandeep Chauhan, the show-cause notices said that during checks conducted at different wholesale drugs license holders, samples of four cough cold syrups containing phenylephrine hydrochloride and chlorpheniramine maleate manufactured by the four pharma companies were taken for test and analysis. "During verification of the labels and on examining the labels of these products, they were found to be misbranded,'' the notice said. The notice said that DGHS-Central Drugs Standard Control Organisation, FDC division had on December 18, 2023 directed that it should be mentioned on the label, package insert and promotional literature of cough cold syrup -"fixed dose combination should not be used in children below 4 years of age". The Union ministry of health and family welfare in exercise of the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 had by a gazette notification of April 15, 2025 restricted the manufacture, sale or distribution of all formulations of fixed dose combination of chlorpheniramine maleate plus phenylephrine hydrochloride subject to the condition that the manufacturers shall mention the warning "fixed dose combination shall not be used in children below four years of age" on the label and package insert or the promotional literature of the drug. Despite the December 2023 orders and April 2025 notification, the manufacturers continued manufacturing, stocking, selling these products and never recalled them, the notice said. The FDA have asked the four pharmaceutical manufacturers to respond in seven days as to why legal action should not be taken against them for contravening the provisions of Drugs and Cosmetics Act 1940 and rules thereunder. The manufacturers have also been asked to produce to furnish information regarding sale invoices of drugs in question (since December 18, 2023), complete batch-wise production records, batch manufacturing records and batch packing records for the batches manufactured in violation of the provision laid under the act, complete list of stock of the product in question, raw material purchase invoices and supplier certificates of analysis for materials used in the implicated batches, copies of any recall letters or communications already sent, corrective action reports....