Famotidine (Page 6 of 6)

17 PATIENT COUNSELING INFORMATION

Central Nervous System (CNS) Adverse Reactions

Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see Warnings and Precautions (5.1)] . Report symptoms immediately to a healthcare provider.

QT Prolongation

Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see Use in Specific Populations (8.6)] . Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider.

Administration

Advise patients:

  • Take famotidine tablets once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
  • Famotidine tablets may be taken with or without food.
  • Famotidine tablets may be given with antacids.

Manufactured by: Celltrion Pharm, Inc
82, 2sandan-ro, Ochang-eup,
Cheongwon-gu, Cheongju-si,
Chungcheongbuk-do, 28117,
Republic of Korea

Manufactured for:
Chartwell RX, LLC. Congers, NY 10920

Revised 12/2023

L71839

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine Tablets, USP — NDC 62135-807-90 — 20 mg — 90s — Bottle Label

"Image Description"
(click image for full-size original)

Famotidine Tablets, USP — NDC 62135-808-90 — 40 mg — 90s — Bottle Label

"Image Description"
(click image for full-size original)
FAMOTIDINE famotidine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-807
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color brown (beige) Score no score
Shape ROUND (barrel shape) Size 9mm
Flavor Imprint Code 1;A6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-807-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075786 09/23/2020
FAMOTIDINE famotidine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-808
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 40 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND (barrel shape) Size 9mm
Flavor Imprint Code 2;A6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-808-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075786 09/23/2020
Labeler — Chartwell RX, LLC (079394054)
Establishment
Name Address ID/FEI Operations
Celltrion Pharm, Inc. 689687234 manufacture (62135-807), manufacture (62135-808)

Revised: 12/2023 Chartwell RX, LLC

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