Famotidine (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine. Packaged in 30 count bottle.

Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Avoid storage of famotidine tablets at temperatures above 40°C (104°F).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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 In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. F 1/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL
(click image for full-size original)

FAMOTIDINE famotidine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1121(NDC:0172-5728)
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
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3000
POLYETHYLENE GLYCOL 4000
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
FERRIC OXIDE RED
TRIACETIN
Product Characteristics
Color brown (beige) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code TEVA;5728
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1121-3 30 TABLET, FILM COATED in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075511 01/01/2019
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-1121), relabel (67296-1121)

Revised: 01/2021 RedPharm Drug, Inc.

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