"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
(Generic versions may still be available.)
DOSAGE AND ADMINISTRATION
It is important that Promethazine HCl and Codeine Phosphate Oral Solution is measured with an accurate measuring device (see PATIENT INFORMATION). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
The average effective dose is given in the following table:
|Adults (12 years of age and over)||5 mL (1 teaspoonful) every 4 to 6 hours, not to exceed 30.0 mL in 24 hours.|
|Children 6 years to under 12 years||2.5 mL to 5 mL (^ to 1 teaspoonful) every 4 to 6 hours, not to exceed 30.0 mL in 24 hours.|
Promethazine HCl and Codeine Phosphate Oral Solution is a clear, purple solution supplied as follows:
NDC 42769-7781-4 -bottles of 4 fl. oz. (118 mL)
NDC 42769-7781-6 – bottles of 16 fl. oz. (473 mL)
Keep bottles tightly closed.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.]
Protect from light.
Dispense in tight, light-resistant container (USP/NF) with a child-resistant closure.
DEA Order Form Required
Manufactured for BayPharma, Inc. Baltimore, MD 21244. Revised May 2013
Last reviewed on RxList: 2/26/2015
This monograph has been modified to include the generic and brand name in many instances.
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