NDC Code(s) : 67546-212-21, 67546-111-12, 67546-111-14
Packager : Romark Laboratories, L.C.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alinianitazoxanide POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67546-212
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITAZOXANIDE(UNII: SOA12P041N)
(NITAZOXANIDE - UNII:SOA12P041N) 		NITAZOXANIDE100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
XANTHAN GUM(UNII: TTV12P4NEE)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
TRIACETIN(UNII: XHX3C3X673)
FD&C RED NO. 40(UNII: WZB9127XOA)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SUCROSE(UNII: C151H8M554)
SODIUM BENZOATE(UNII: OJ245FE5EU)
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67546-212-211 in 1 CARTON 22/11/2002
160 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021498 11/22/2002
Alinianitazoxanide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67546-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITAZOXANIDE(UNII: SOA12P041N)
(NITAZOXANIDE - UNII:SOA12P041N) 		NITAZOXANIDE500 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SUCROSE(UNII: C151H8M554)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
POLYVINYL ALCOHOL(UNII: 532B59J990)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color yellow (yellow) Score no score
Shape ROUND (ROUND) Size 13 mm
Flavor Imprint Code ALINIA;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67546-111-121 in 1 CARTON 21/07/2004
130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:67546-111-141 in 1 CARTON 21/07/2004
212 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021497 07/21/2004

LABELER - Romark Laboratories, L.C.(877685123)

PRINCIPAL DISPLAY PANEL

NDC 67546-111-12

Alinia®

(nitazoxanide) tablets

500 mg

Rx Only 30 TABLETS

Alinia Tablets - 30 ct Label

PRINCIPAL DISPLAY PANEL

NDC 67546-111-12

Alinia (nitazoxanide) tablets

500 mg

Rx Only 30 TABLETS

Alinia Tablet - 30 ct carton

PRINCIPAL DISPLAY PANEL

NDC 67546-111-17

Alinia®

(nitazoxanide) tablets

500 mg

Rx only 2 TABLETS SAMPLE

Alinia Tablets - 2 ct container label

PRINCIPAL DISPLAY PANEL

NDC 67546-111-17

Alinia (nitazoxanide) tablets

500 mg

SAMPLE NOT FOR RESALE

Romark logo

Rx Only 2 TABLETS

Alinia Tablets - 2 ct carton

PRINCIPAL DISPLAY PANEL

NDC 67546-111-14

Alinia® (nitazoxinde) tablets

500 mg

Rx only 12 TABLETS

Alinia Tablets - 12 ct Label

PRINCIPAL DISPLAY PANEL

NDC 67546-111-14

Alinia®

(nitazoxanide) tablets

500 mg

Romark Logo

Rx only 12 TABLETS

Alinia Tablets - 12 ct Carton

PRINCIPAL DISPLAY PANEL

NDC 67546-212-21

Alinia (nitazoxanide) for Oral Suspension 100 mg/5 mL

Reconstitute with 48 mL water

SHAKE WELL BEFORE USING

Any unused protion must be discarded 7 days after mixing

60 mL reconstituted

Rx only

Alinia for Oral Suspension- Container Label

PRINCIPAL DISPLAY PANEL

Alinia OS CartonNDC 67546-212-21

Alinia (nitazoxanide) for Oral Suspension 100 mg/5 mL

Reconstitute with 48 mL water

SHAKE WELL BEFORE USING

Any unused portion must be discarded 7 days after mixing

60 mL

Rx only