te-release amoxicillin can be substituted for MOXATAG.
17.2 Hypersensitivity Reactions
Patients should be informed that serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported while on penicillin therapy. Patients should be questioned regarding any hypersensitivity reactions to penicillins, cephalosporins or other allergens. Whenever such reactions occur, the patient should be instructed to contact their physician immediately. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
17.3 Clostridium difficile Associated Diarrhea
Patients should be informed that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
AUGMENTIN is a registered trademark of GlaxoSmithKline.
CLINITEST is a registered trademark of Miles, Inc.
CLINISTIX is a registered trademark of Bayer Corporation.
MOXATAG is a trademark of MiddleBrook Pharmaceuticals, Inc., all rights reserved.
Manufactured in Clonmel, Ireland by Stada Production Ireland for
MiddleBrook Pharmaceuticals, Inc., Germantown, Maryland 20876
U.S. Patents 6,544,555; 6,669,948; 6,723,341
Issue Date 06/08
PC2049L/1
Copyright © 2008, MiddleBrook Pharmaceuticals, Inc. All rights reserved.
INGREDIENTS AND APPEARANCE
MOXATAG
amoxicillin tablet, extended release
Product Information
Product Type Item Code (Source) NDC:11042-142
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amoxicillin (UNII: 804826J2HU) (amoxicillin - UNII:804826J2HU) 775 mg
Inactive Ingredients
Ingredient Name Strength
Crospovidone ()
FD&C Blue #2 lake ()
hypromellose ()
hypromellose acetate succinate ()
iron oxide ()
magnesium stearate (UNII: 70097M6I30)
methacrylic acid copolymer ()
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol 400 ()
polyoxyl 35 castor oil ()
shellac ()
colloidal silicon dioxide (UNII: ETJ7Z6XBU4)
sodium lauryl sulfate (UNII: 368GB5141J)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)
triethyl citrate (UNII: 8Z96QXD6UM)
Product Characteristics
Color blue (BLUE) Score no score
Shape OVAL (OVAL) Size 22mm
Flavor Imprint Code MB-111
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11042-142-03 30 in 1 BOTTLE
2 NDC:11042-142-02 10 in 1 BLISTER PACK
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