Ibuprofen and Famotidine (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0093-8107-98

Ibuprofen and Famotidine Tablets

800 mg/26.6 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

90 Tablets

Label
(click image for full-size original)
IBUPROFEN AND FAMOTIDINE ibuprofen and famotidine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 26.6 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2–ALUMINUM LAKE
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
TALC
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color blue (light blue to blue) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code TEVA;8107
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-8107-98 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211278 12/15/2021
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2021 Teva Pharmaceuticals USA, Inc.

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