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Diphenhydramine

     

 

DESCRIPTION---Benadryl®

Diphenhydramine hydrochloride, is an antihistamine drug having the chemical name 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride and has the empirical formula C17H21NO¡¤HCl. It occurs as a white, crystalline powder and is freely soluble in water and alcohol and has a molecular weight of 291.82.

Each diphenhydramine HCl capsule contains 25 mg or 50 mg diphenhydramine hydrochloride for oral administration.

Each Benadryl 25-mg capsule also contains lactose, NF and magnesium stearate, NF. The capsule shell and/or band contains D&C red No. 28; FD&C blue No. 1; FD&C red No. 3; FD&C red No. 40; gelatin, NF; colloidal silicon dioxide, NF; and sodium lauryl sulfate, NF.

Each Benadryl 50-mg capsule also contains confectioner's sugar, NF and talc, USP. The capsule shell and/or band contains FD&C blue No. 1; FD&C red No. 3; gelatin, NF; glyceryl monooleate; colloidal silicon dioxide, NF; sodium lauryl sulfate, NF; and titanium dioxide, USP.

Each 5 ml of diphenhydramine HCl elixir contains 12.5 mg diphenhydramine HCl with 14% alcohol for oral administration.

Diphenhydramine HCl in the parenteral form is a sterile, pyrogen-free solution available in two concentrations: 10 mg and 50 mg of diphenhydramine hydrochloride per ml. The solutions for parenteral use have been adjusted to a pH between 5.0 and 6.0 either with sodium hydroxide or hydrochloric acid. The multidose Steri-Vials contain 0.1 mg/ml benzethonium chloride as a germicidal agent.

 

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