Prescription Drug Information: Famotidine (Page 5 of 5)

14.6 Risk Reduction of Duodenal Ulcer Recurrence

Two randomized, double-blind, multicenter trials in patients with endoscopically confirmed healed DUs demonstrated that patients receiving treatment with orally administered famotidine 20 mg at bedtime had lower rates of DU recurrence, as compared with placebo.

  • In the U.S. trial, DU recurrence within 12 months was 2.4 times greater in patients treated with placebo than in the patients treated with famotidine. The 89 famotidine tablets-treated patients had a cumulative observed DU recurrence rate of 23%, compared to a 57% in the 89 patients receiving placebo (p<0.01).
  • In the international trial, the cumulative observed DU recurrence within 12 months in the 307 famotidine tablets-treated patients was 36%, compared to 76% in the 325 patients who received placebo (p<0.01).

Controlled trials have not extended beyond one year.

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

NDC: 70518-0460-00

NDC: 70518-0460-01

NDC: 70518-0460-02

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 60 in 1 BOTTLE PLASTIC

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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

DRUG: Famotidine

GENERIC: Famotidine

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0460-0

NDC: 70518-0460-1

NDC: 70518-0460-2

COLOR: brown

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: TEVA;5728

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 60 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • FAMOTIDINE 20mg in 1

INACTIVE INGREDIENT(S):

  • 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
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
MM3
(click image for full-size original)
FAMOTIDINE famotidine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0460(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:70518-0460-0 30 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:70518-0460-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:70518-0460-2 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075511 04/25/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 06/2022 REMEDYREPACK INC.

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