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diphenhydramine hydrochloride + ammonium chloride + sodium citrate Syrup 12.5 mg + 125 mg + 50 mg/5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Indonesia
GMP approvals
Indonesia
Manufacturer #20654

This CTD dossier owner and manufacturer, based in Southeast Asia, has been operating for several decades, specializing in the production of over 80 pharmaceutical products. They offer a wide range of ethical, over-the-counter, and herbal medications, as well as food supplements. Their product portfolio includes cephalosporin-based drugs, highlighting their expertise in anti-infectives. Their facilities, spanning over 6,800 square meters, ensure the production of high-quality and affordable medicines for the region. While specific therapy areas are not mentioned, their product focus suggests a focus on general health, with a possible emphasis on infectious diseases. Their production lines include solid, liquid, and injectable dosage forms. Their products meet Good Manufacturing Practice (GMP) standards for both the European Union and the United States, indicating a commitment to global quality standards.

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Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride as the name suggests is the hydrochloride salt form of diphenhydramine. It is a first-generation histamine antagonist and an ethanolamine with anti- allergic activity. Diphenhydramine Hydrochloride relieves symptoms of red, irritated, itchy, watery eyes, sneezing, runny nose caused by hay fever, allergies, or the common cold and cough caused by airway irritation. It has antiemetic, antitussive, hypnotic, and antiparkinson properties. When used to cure allergies, its receptors exist both peripherally and in the CNS and can sedate as an antagonist of histamine H1 receptors in the CNS. Due to its sedative effect, it is not the first choice of medicine for curing allergies. However, it has been used in many non-prescription OTC sleep medicines and cough-and-cold medications sold for nighttime use. Diphenhydramine Hydrochloride is sold under the brand names like Allerdryl, Benadryl, Benhydramin and Benylin to name a few. George Rieveschl, a former professor at the University of Cincinnati discovered it in 1943. It has the distinction of being the first prescription antihistamine approved by the U.S. FDA In 1946. Further research in the 1960s revealed that its effective in inhibiting the reuptake of neurotransmitter serotonin.

Dosage and administration

Diphenhydramine Hydrochloride is sold as tablets and capsules. The recommended dose for adults and children older than 12 years is 25 mg to 50 mg or 1 to 2 capsules. The pediatric dose for children aged 6 to 12 years, is 12.5 mg. and parents should consult for dose in kids younger than 6 years.

The cost of Diphenhydramine Hydrochloride

In the USA, the consumers pay an average retail price of $5 for a generic 30 capsules of 25mg. However, this medicine is significantly cheaper in the developing world. In India, for 20 capsules, the consumers pay an average retail price of USD0.40 or 40 cents.

How does Diphenhydramine Hydrochloride Work?

Diphenhydramine hydrochloride competitively blocks H1receptors. This results in the prevention of histamine actions on bronchial smooth muscle, capillaries, and gastrointestinal smooth muscle. This achieves the desired reduction in histamine-induced bronchoconstriction, vasodilation, increased capillary permeability, and GI smooth muscle spasms. Diphenhydramine hydrochloride has antitussive, hypnotic, antiemetic, and antiparkinson actions. In its actions in curing allergies, its receptors exist both peripherally and in the CNS and can sedate as an antagonist of histamine H1 receptors in the CNS. Due to its sedative effect, it is not the first choice of medicine for curing allergies.

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