Source: FDA, National Drug Code (US) Revision Year: 2021
The active ingredient in ROWASA (mesalamine) Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid.
The empirical formula is C7H7NO3, representing a molecular weight of 153.14.
The structural formula is:
Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.
| How Supplied |
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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 0037-0066-01 Professional Sample ROWASA (mesalamine) Rectal Suspension Enemas are for rectal use only. KEEP OUT OF REACH OF CHILDREN Patient instructions are included. Distributed by: Meda, Pharmaceuticals, Somerset, New Jersey 08873-4120 |
| Drug | Countries | |
|---|---|---|
| ROWASA | France, Tunisia, United States |
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