NDC 65162-0521-10

Promethazine Hydrochloride 25 mg/1 TABLET

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NDC

65162-0521-10

Generic Name

Promethazine Hydrochloride

Brand Name

Promethazine Hydrochloride

Strength

25 mg/1

Dosage Form

TABLET

Route

ORAL

Package Size

—

Labeler

Amneal Pharmaceuticals LLC

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Promethazine Hydrochloride Tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, p…

Important Warnings

WARNINGS Promethazine hydrochloride should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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Other Promethazine Hydrochloride NDC Codes

39822-5525-0325 mg/mLINJECTION, SOLUTION

2-Day

39822-5550-0650 mg/mLINJECTION, SOLUTION

2-Day

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