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NDC 50269-0155-01 Zantac 360 1 per blister 6 blisters 20 mg/1 Details

Zantac 360 1 per blister 6 blisters 20 mg/1

Zantac 360 1 per blister 6 blisters is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by JC World Bell Wholesale Co., Inc.. The primary component is FAMOTIDINE.

MedlinePlus Drug Summary

Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.

Related Packages: 50269-0155-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Famotidine

Product Information

NDC	50269-0155
Product ID	50269-155_e60e66b0-5f87-4879-e053-2995a90a8c5a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Zantac 360 1 per blister 6 blisters
Proprietary Name Suffix	n/a
Non-Proprietary Name	FAMOTIDINE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/1
Substance Name	FAMOTIDINE
Labeler Name	JC World Bell Wholesale Co., Inc.
Pharmaceutical Class	Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206531
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50269-0155-01 (50269015501)

Pricing Information	N/A
NDC Package Code	50269-155-01
Billing NDC	50269015501
Package	6 BLISTER PACK in 1 BOX (50269-155-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2021-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b55d4a6d-e2f0-490b-9ca2-caa7eb998eec Details

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 20mg

Purpose

Acid reducer

Uses

relieves heartburn associated with acid indigestion and sour stomach
prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask a doctor before use if you have

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with

lightheadedness, sweating, or dizziness

chest pain or shoulder pain with shortness or breath; sweating, pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

your heartburn continues or worsens
you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 12 years and over:
to relieve symptoms, swallow 1 tablet with a glass or water. Do not chew.
to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
do not use more than 2 tablets in 24 hours
children under 12 years: ask a doctor

Other information

read the directions and warnings before use
keep the carton. It contains important information.
store at 20°25°C (68°F-77°F)
protect from moisture

Inactive ingredients

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide

Questions or comments?

call 1-800-633-1610 or visit www.zantacotc.com

Package Labeling:

INGREDIENTS AND APPEARANCE

ZANTAC 360 1 PER BLISTER 6 BLISTERS

famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50269-155(NDC:41167-0361)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	CC;59
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50269-155-01	6 in 1 BOX	10/01/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206531	10/01/2021

Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Revised: 8/2022

Document Id: e60e66b0-5f87-4879-e053-2995a90a8c5a

Set id: b55d4a6d-e2f0-490b-9ca2-caa7eb998eec

Version: 1

Effective Time: 20220812