Labzine Elixir_

Promethazine hydrochloride tablets, USP 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, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. …

• Promethazine hydrochloride tablets, USP are contraindicated for children under 2 years of age (see WARNINGS - Black Box Warning and Use
• In Pediatric Patients )
• Promethazine hydrochloride tablets, USP are for oral administration only
• Allergy The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary
• Single 25 mg doses at bedtime or 6.25 mg to 12.5 mg taken three times daily will usually suffice
• After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms
• The administration of promethazine hydrochloride in 25 mg doses will control minor transfusion reactions of an allergic nature
• Motion Sickness The average adult dose is 25 mg taken twice daily
• The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary
• On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal
• For children, promethazine hydrochloride tablets, USP 12.5 mg to 25 mg, twice daily, may be administered
• Nausea and Vomiting Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS - Use
• In Pediatric Patients )
• The average effective dose of promethazine hydrochloride tablets, USP for the active therapy of nausea and vomiting in children or adults is 25 mg. 12.5 to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals. …

• Promethazine hydrochloride tablets, USP are contraindicated for use
• In pediatric patients less than two years of age
• Promethazine hydrochloride tablets, USP are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines
• Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma

WARNING: PROMETHAZINE HYDROCHLORIDE TABLETS, USP 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 TABLETS, USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS, USP TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. …

Central Nervous System Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular — Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic — Dermatitis, photosensitivity, urticaria. Hematologic — Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. …

Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensorplantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.