Description
DESCRIPTION
Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful), for oral administration contains: Promethazine …
CLINICAL PHARMACOLOGY
Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is …
INDICATIONS AND USAGE
Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the …
CONTRAINDICATIONS
Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other …
WARNINGS
WARNING – 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 …
PRECAUTIONS
Animal reproduction studies have not been conducted with the drug combination–promethazine and phenylephrine. It is not known whether this drug combination can cause fetal harm when administered …
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Promethazine – Central Nervous System – Drowsiness …
OVERDOSAGE
Promethazine – Signs and symptoms of overdosage with promethazine HCI range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory …
DOSAGE AND ADMINISTRATION
Promethazine hydrochloride and phenylephrine hydrochloride syrup is contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients). The …
HOW SUPPLIED
This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent …
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
AKORN – PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SYRUP – 6.25 mg/5 mg PER 5 mL – EACH 5 mL (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride ………………………..6.25 …
INGREDIENTS AND APPEARANCE
Product Information
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