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NDC 54257-0802-02 Famotidine 20 mg/1 Details

Famotidine 20 mg/1

Famotidine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Magno-Humphries, 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: 54257-0802-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Famotidine

Product Information

NDC	54257-0802
Product ID	54257-802_86008c15-a2ce-4c0b-8323-5a0caa7f2570
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	Famotidine
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	Magno-Humphries, 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 54257-0802-02 (54257080202)

Pricing Information	N/A
NDC Package Code	54257-802-02
Billing NDC	54257080202
Package	100 TABLET, FILM COATED in 1 BOTTLE (54257-802-02)
Marketing Start Date	2016-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 20 mg

Purpose

Acid reducer

Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents 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.
if you have kidney disease, except under the advice and supervision of a 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 of 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

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 of 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

• store at 20° to 25°C (68° to 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 and yellow iron oxide.

Questions or comments?

call 1-800-935-6737

Tips for Managing Heartburn

Do not lie flat or bend over after eating
Do not wear tight-fitting clothing around the stomach
Do not eat before bedtime
Raise the head of your bed
Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
Eat slowly and avoid big meals
If overweight, lose weight
Quit smoking

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Do not use if printed foil seal under bottle cap is open or torn.

Distributed by:

Magno-Humphries Labs

Tigard, OR 97223, U.S.A.

Visit our website: www.magno-humphries.com

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets, Container Label)

MHL℗

*Compare to the Active Ingredient

of Maximum Strength Pepcid® AC

MAXIMUM STRENGTH

FAMOTIDINE

TABLETS USP 20 mg

ACID REDUCER

Just One Tablet Prevents & Relieves

Heartburn Due to Acid Indigestion

100 TABLETS

INGREDIENTS AND APPEARANCE

FAMOTIDINE

famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54257-802
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 (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND (Square shaped Biconvex)	Size	5mm
Flavor		Imprint Code	CC;59
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54257-802-02	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206531	04/26/2016

Labeler - Magno-Humphries, Inc. (063251433)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650844777	ANALYSIS(54257-802) , MANUFACTURE(54257-802)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(54257-802) , MANUFACTURE(54257-802)

Revised: 12/2021

Document Id: 86008c15-a2ce-4c0b-8323-5a0caa7f2570

Set id: f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9

Version: 5

Effective Time: 20211224