AMOXICILLIN by DIRECTRX / DIRECT RX AMOXICILLIN capsule

AMOXICILLIN by

Drug Labeling and Warnings

AMOXICILLIN by is a Prescription medication manufactured, distributed, or labeled by DIRECTRX, DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

USE IN SPECIFIC POPULATIONS

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

14 CLINICAL STUDIES

13 NONCLINICAL TOXICOLOGY

15 REFERENCES

17 PATIENT COUNSELING INFORMATION

500 mg Capsule Label

INGREDIENTS AND APPEARANCE

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)