Nitrofurantoin Monohydrate/ Macrocrystalline (Page 4 of 4)
Storage and Handling
Store at controlled room temperature (59° to 86°F or 15° to 30°C).
Meets USP Dissolution Test 2
Rx Only
REFERENCES
- Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Eighth Edition. CLSI document M07-A8 [ISBN 1-56238-689-1]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.
- Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard- Tenth Edition. CLSI document M02-A 10 [ISBN 1-56238-688-3]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.
- Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Nineteenth Informational Supplement. CLSI document M100-S19 [ISBN 1-56238-716-2]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2010.
CLINICAL STUDIES
Controlled clinical trials comparing Nitrofurantoin monohydrate/macrocrystals capsules 100 mg p.o. q12h and Macrodantin 50 mg p.o. q6h in the treatment of acute uncomplicated urinary tract infections demonstrated approximately 75% microbiologic eradication of susceptible pathogens in each treatment group.
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Mfg. By: Norwich Pharmaceuticals, Inc.
6826 State Highway 12
Norwich, NY 13815 USA
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Distributed by: Alvogen, Inc.
Pine Brook, NJ 07058 USA
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Rev: 06/2012 PI303-03
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To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
| NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE nitrofurantoin monohydrate/macrocrystalline capsule | ||||||||||||||||||||||||||
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| Labeler — Clinical Solutions Wholesale (078710347) |
| Registrant — Clinical Solutions Wholesale (078710347) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Clinical Solutions Wholesale | 078710347 | repack (58118-0303), relabel (58118-0303) | |
Revised: 08/2013 Clinical Solutions Wholesale
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