Aemcolo (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 194 mg Tablet Blister Pack Carton

Rx only
NDC 57841-1201-1

194 mg tablets*

Swallow tablet whole.
Do not chew or break.

Aemcolo®
(rifamycin)
delayed
release tablets

Sample/Not for Sale

*Each tablet contains:
Rifamycin 194 mg
(equivalent to 200 mg Rifamycin Sodium Salt)

aemcolo.com

4 tablets
(1 card x 4 tablets)

PRINCIPAL DISPLAY PANEL -- 194 mg Tablet Blister Pack Carton (Sample)
(click image for full-size original)
AEMCOLO rifamycin tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57841-1200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Rifamycin (Rifamycin) Rifamycin 194 mg
Inactive Ingredients
Ingredient Name Strength
Ammonio methacrylate copolymer type B 159 mg
Ascorbic Acid 20 mg
Glyceryl distearate 20 mg
LECITHIN, SOYBEAN 10 mg
Magnesium stearate 25 mg
MANNITOL 470 mg
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:2) 150 mg
Polyethylene glycol 6000 1 mg
SILICON DIOXIDE 15 mg
Talc 16.7 mg
Titanium Dioxide 2 mg
Triethyl citrate 2.3 mg
FERRIC OXIDE YELLOW 6 mg
Product Characteristics
Color BROWN (Yellow Brown) Score no score
Shape BULLET (Ellipsoidal) Size 19mm
Flavor Imprint Code SV2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57841-1200-1 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK (57841-1200-0)
1 NDC:57841-1200-0 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (57841-1200-1)
2 NDC:57841-1200-2 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK (57841-1200-0)
2 NDC:57841-1200-0 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (57841-1200-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210910 07/01/2021
AEMCOLO rifamycin tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57841-1201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Rifamycin (Rifamycin) Rifamycin 194 mg
Inactive Ingredients
Ingredient Name Strength
Ammonio methacrylate copolymer type B 159 mg
Ascorbic Acid 20 mg
Glyceryl distearate 20 mg
LECITHIN, SOYBEAN 10 mg
Magnesium stearate 25 mg
MANNITOL 470 mg
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:2) 150 mg
Polyethylene glycol 6000 1 mg
SILICON DIOXIDE 15 mg
Talc 16.7 mg
Titanium Dioxide 2 mg
Triethyl citrate 2.3 mg
FERRIC OXIDE YELLOW 6 mg
Product Characteristics
Color BROWN (Yellow Brown) Score no score
Shape BULLET (Ellipsoidal) Size 19mm
Flavor Imprint Code SV2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57841-1201-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (57841-1201-0)
1 NDC:57841-1201-0 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (57841-1201-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210910 07/01/2021
Labeler — RedHill Biopharma Ltd (533278342)

Revised: 07/2021 RedHill Biopharma Ltd

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