Promethazine HCl and Dextromethorphan Hydrobromide Syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

It is important that Promethazine HCl and Dextromethorphan Hydrobromide Syrup is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). 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.

Promethazine HCl and Dextromethorphan Hydrobromide Syrup is CONTRAINDICATED for children under 2 years of age (see WARNINGS – Boxed Warning and Use in Pediatric Patients).

The average effective dose for adults is 5 mL (one teaspoon) every 4 to 6 hours, not to exceed 30.0 mL in 24 hours. For children 6 years to under 12 years of age, the dose is 2.5 to 5.0 mL (one-half to one teaspoon) every 4 to 6 hours, not to exceed 20.0 mL in 24 hours. For children 2 years to under 6 years of age, the dose is 1.25 to 2.5 mL (one-quarter to one-half teaspoon) every 4 to 6 hours, not to exceed 10.0 mL in 24 hours.

Promethazine HCl and Dextromethorphan Hydrobromide Syrup is a clear, yellow solution supplied as follows:

NDC 62559-7581-4 – bottle of 4 fl. oz. (118 mL)
NDC 62559-7581-6 – bottle 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.

Manufactured by: ANI Pharmaceuticals, Inc. Baltimore, MD 21244. Rev 03/08. FDA Rev date: 4/2/2008

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