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
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
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| Labeler — REMEDYREPACK INC. (829572556) |
Revised: 06/2022 REMEDYREPACK INC.
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