METRONIDAZOLE- metronidazole tablet 
REMEDYREPACK INC.

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BOXED WARNING

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

GERIATRIC USE

PEDIATRIC USE

ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

REFERENCES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

MM12

METRONIDAZOLE 
metronidazole tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49349-970(NDC:0591-2522)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE500 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeBULLET (TABLET) Size16mm
FlavorImprint Code WPI;39;70
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-970-0414 in 1 BLISTER PACK; Type 0: Not a Combination Product07/10/201212/02/2015
2NDC:49349-970-0230 in 1 BLISTER PACK; Type 0: Not a Combination Product07/10/201211/21/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01876407/10/201212/02/2015
Labeler - REMEDYREPACK INC. (829572556)
Establishment
NameAddressID/FEIBusiness Operations
REMEDYREPACK INC.829572556repack(49349-970)

Revised: 10/2016
Document Id: 3e109713-e222-6ce9-e054-00144ff8d46c
Set id: 17b4618b-fd28-413f-8ec9-fbae2f63cf3f
Version: 4
Effective Time: 20161004
 
REMEDYREPACK INC.