Tinidazole (Page 5 of 5)

16 HOW SUPPLIED/STORAGE & HANDLING

Tinidazole Tablets 250 mg tablets are pink, round, scored tablets, debossed with “N” scored “L” on one side and “550” on the other side, supplied in bottles with child-resistant caps as:

NDC 40032-550-40 Bottle of 40
NDC 40032-550-08 Bottle of 8

Tinidazole Tablets 500 mg tablets are pink, oval, scored tablets, debossed with “N” scored “L” on one side and “551” on the other side, supplied in bottles with child-resistant caps as:

NDC 40032-551-60 Bottle of 60
NDC 40032-551-20 Bottle of 20

Storage: Store at controlled room temperature 20°-25° C (68°-77° F) [see USP Controlled Room Temperature]. Protect contents from light.

17 INFORMATION FOR PATIENTS

17.1 Administration of Drug

Patients should be told to take Tinidazole Tablets with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole.

17.2 Alcohol Avoidance

Patients should be told to avoid alcoholic beverages and preparations containing ethanol or propylene glycol during Tinidazole Tablets therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.

17.3 Drug Resistance

Patients should be counseled that antibacterial drugs including Tinidazole Tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Tinidazole Tablets is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Tinidazole Tablets or other antibacterial drugs in the future.

Manufactured by:
Novel Laboratories, Inc.
400 Campus DriveSomerset, NJ 08873

NIN-551-00

TINIDAZOLE tinidazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-550 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TINIDAZOLE (TINIDAZOLE) TINIDAZOLE 250 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL 3000 TALC FD&C RED NO. 40 CROSCARMELLOSE SODIUM

Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code NL;550 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:40032-550-08 8 TABLET (TABLET) in 1 BOTTLE None 2 NDC:40032-550-40 40 TABLET (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202044 04/30/2012

TINIDAZOLE tinidazole tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-551 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TINIDAZOLE (TINIDAZOLE) TINIDAZOLE 500 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL 3000 TALC FD&C RED NO. 40 CROSCARMELLOSE SODIUM

Product Characteristics Color PINK Score 2 pieces Shape OVAL Size 16mm Flavor Imprint Code NL;551 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:40032-551-20 20 TABLET (TABLET) in 1 BOTTLE None 2 NDC:40032-551-60 60 TABLET (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202044 04/30/2012

Labeler — Novel Laboratories, Inc. (793518643)

Registrant — Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Operations
Novel Laboratories, Inc.		793518643	MANUFACTURE, ANALYSIS

Revised: 05/2012 Novel Laboratories, Inc.