AMOXICILLIN- amoxicillin capsule
DIRECTRX
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AMOXICILLIN 500mg 30 TABS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
14 CLINICAL STUDIES
13 NONCLINICAL TOXICOLOGY
15 REFERENCES
17 PATIENT COUNSELING INFORMATION
500 mg Capsule Label
AMOXICILLIN
amoxicillin capsule
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:61919-355(NDC:67253-150)
Route of Administration
ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
AMOXICILLIN
(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
AMOXICILLIN ANHYDROUS
500 mg
Inactive Ingredients
Ingredient Name
Strength
ISOPROPYL ALCOHOL
(UNII: ND2M416302)
BUTYL ALCOHOL
(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL
(UNII: 6DC9Q167V3)
MAGNESIUM STEARATE
(UNII: 70097M6I30)
POTASSIUM HYDROXIDE
(UNII: WZH3C48M4T)
WATER
(UNII: 059QF0KO0R)
CELLULOSE, MICROCRYSTALLINE
(UNII: OP1R32D61U)
SHELLAC
(UNII: 46N107B71O)
AMMONIA
(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE
(UNII: XM0M87F357)
ALCOHOL
(UNII: 3K9958V90M)
FERRIC OXIDE YELLOW
(UNII: EX438O2MRT)
TITANIUM DIOXIDE
(UNII: 15FIX9V2JP)
GELATIN
(UNII: 2G86QN327L)
Product Characteristics
Color
yellow (Opaque)
Score
no score
Shape
CAPSULE
Size
22mm
Flavor
Imprint Code
AMOX;500;GG;849
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:61919-355-30
30 in 1 BOTTLE; Type 0: Not a Combination Product
04/11/2016
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA064076
04/11/2016
Labeler -
DIRECTRX (079254320)
Establishment
Name
Address
ID/FEI
Business Operations
DIRECT RX
079254320
repack(61919-355)
Revised: 4/2016
Document Id:
30635424-e6bd-1bff-e054-00144ff88e88
Set id: 30635424-e6bc-1bff-e054-00144ff88e88
Version: 1
Effective Time: 20160413
DIRECTRX
