ROWASA® (Mesalamine) Rectal Suspension Enema for rectal administration is an off-white to tan colored suspension. Each disposable enema bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Enema bottles are supplied in boxed, foil-wrapped trays as follows:.
NDC 68220-066-07........................... Carton of 7 Bottles
NDC 68220-066-28........................... Carton of 28 Bottles
ROWASA® (Mesalamine) Rectal Suspension Enemas are for rectal use only.
KEEP OUT OF REACH OF CHILDREN
Patient instructions are included.
Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted, please refer to current USP. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.
NOTE: ROWASA® (Mesalamine) Rectal Suspension Enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.
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ALAVEN Pharmaceutical LLC
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Marietta, GA 30067
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