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

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

(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.