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NDC 68016-0008-01 Premier Value Famotidine 20 mg/1 Details

Premier Value Famotidine 20 mg/1

Premier Value Famotidine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Premier Value. 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: 68016-0008-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Famotidine

Product Information

NDC	68016-0008
Product ID	68016-008_7ab337e1-90e1-4233-b854-19aee40ccfbe
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	Premier Value 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	Premier Value
Pharmaceutical Class	Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090283
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68016-0008-01 (68016000801)

Pricing Information	N/A
NDC Package Code	68016-008-01
Billing NDC	68016000801
Package	25 TABLET, FILM COATED in 1 BOTTLE (68016-008-01)
Marketing Start Date	2010-07-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 42d1e2f2-9b9b-4a6d-9fc1-047e167153b5 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

with other acid reducers
if you have kidney disease, except under the advice and supervision of a doctor
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.

Ask a doctor before use if you have

frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
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

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 right away (1-800-222-1222).

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

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

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions?

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

†COMPARE TO THE ACTIVE INGREDIENT

IN MAXIMUM STRENGTH PEPCID AC®

Premier

Value ®

MAXIMUM STRENGTH

Famotidine Tablets, USP 20 mg

Acid Controller

Acid Reducer

✓: Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

25 Tablets

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Label

Premier

Value ®

MAXIMUM STRENGTH

Famotidine Tablets, USP 20 mg

Acid

Controller

Acid Reducer

✓: Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

25 Tablets

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Label

INGREDIENTS AND APPEARANCE

PREMIER VALUE FAMOTIDINE

famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-010
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	035
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68016-010-81	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/25/2010
2	NDC:68016-010-82	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090283	06/25/2010

PREMIER VALUE FAMOTIDINE

famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-008
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	036
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-008-01	25 in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090283	07/23/2010

Labeler - Premier Value (101668460)

Registrant - Sun Pharmaceutical Industries Inc. (146974886)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	manufacture(68016-010, 68016-008)

Revised: 12/2019

Document Id: 7ab337e1-90e1-4233-b854-19aee40ccfbe

Set id: 42d1e2f2-9b9b-4a6d-9fc1-047e167153b5

Version: 4

Effective Time: 20191227

Search by Drug Name or NDC

NDC 68016-0008-01 Premier Value Famotidine 20 mg/1 Details

Premier Value Famotidine 20 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68016-0008-01 (68016000801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 42d1e2f2-9b9b-4a6d-9fc1-047e167153b5 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Allergy alert

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Label

INGREDIENTS AND APPEARANCE

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