Promethazine 12.5 mg Tablets — Generic For Phenergan — Amneal

Medication Summary

Medication Summary: This section summarizes DailyMed drug label information to make the label easier to understand. It is not a substitute for the official label, pharmacist counseling, prescriber instructions, or medical advice.

Overview

Promethazine Hydrochloride Tablets, USP are prescription medicines available in 12.5 mg, 25 mg, and 50 mg strengths. The label says promethazine is an H1 receptor blocking agent with antihistaminic, sedative, and antiemetic effects.

These tablets are used for several allergy-related conditions, motion sickness, nausea and vomiting, and sedation in children and adults. They are also listed for certain preoperative, postoperative, and obstetric uses, and as an adjunct in some allergic reactions after acute symptoms are controlled.

The label includes important warnings about serious side effects such as drowsiness, respiratory depression, and interactions with alcohol or other central nervous system depressants. Promethazine hydrochloride tablets are contraindicated in children under 2 years of age and in people with certain conditions or hypersensitivity to the drug.

Storage Information

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

Key Counseling Points

• This medicine may cause marked drowsiness and can impair driving or operating machinery.
• Avoid alcohol and be cautious with other central nervous system depressants, such as sedatives, narcotics, and tranquilizers.
• Do not use in children under 2 years of age.
• Tell the prescriber if the patient has asthma or other lower respiratory tract symptoms, since antihistamines are contraindicated for those symptoms.
• Report involuntary muscle movements, unusual excitement, confusion, or hallucinations.
• Avoid prolonged exposure to the sun.
• Use caution in people with glaucoma, prostate enlargement, stomach or urinary obstruction, or liver disease.
• If taking this medicine with other drugs, note that it may interact with MAO inhibitors, anticholinergics, and some laboratory tests.
• Serious breathing problems have been reported, especially in young children and with other respiratory depressants.
• The medicine is used for allergy symptoms, motion sickness, nausea and vomiting, and sedation as described on the label.

Helpful Patient Education

Promethazine Hydrochloride Tablets, USP are prescription oral tablets available in 12.5 mg, 25 mg, and 50 mg strengths. According to the DailyMed label, promethazine is an H1 receptor blocking agent with antihistaminic, sedative, and antiemetic effects, and it is used for allergic conditions, motion sickness, nausea and vomiting, and certain sedation-related uses.

Label information also highlights important safety considerations, including drowsiness, possible respiratory depression, and interactions with alcohol and other central nervous system depressants. The tablets are contraindicated for children under 2 years of age and should be used according to the prescribing information.

Medication Summary last generated: 2026-07-19 02:56:39