Famotidine (Page 5 of 5)

16 How Supplied/Storage and Handling

Famotidine 20 mg tablets are white, round, film-coated tablets engraved with CTI 121 on one side, supplied as follows:


Boxes of 10×10 UD 100 NDC 63739-645-10


Storage
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense in a tight, light-resistant container.

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:
Carlsbad Technology, Inc.
5923 Balfour Ct. Carlsbad, CA 92008 USA


Distributed by:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141


21315-3 June 2022

Famotidine

Famotidine
(click image for full-size original)

FAMOTIDINE famotidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-645(NDC:61442-121)
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TRIACETIN
TITANIUM DIOXIDE
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code CTI;121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-645-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-645-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075805 04/16/2001
Labeler — Mckesson Corporation DBA SKY Packaginng (140529962)

Revised: 06/2022 Mckesson Corporation DBA SKY Packaginng

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