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 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