FAMOTIDINE tablet, film coated

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by Fred's, Inc., Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• keep the carton. It contains important information.
• 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 1-855-274-4122

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 carton is open or if printed foil seal under bottle cap is open or torn.

Distributed by: Fred's Inc
4300 New Getwell Road
Memphis, TN 38118
www.fredsinc.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (25 Tablets Container Label)

Fred's
Pharmacy

NDC: 55315-435-53
MAXIMUM STRENGTH
Acid Reducer
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion

25 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (25 Tablets Container Carton Label)

fred's
Pharmacy

NDC: 55315-435-53
*Compare to the Active Ingredient in:
Maximum Strength Pepcid® AC

MAXIMUM STRENGTH
Acid Reducer
Famotidine
Tablets USP 20 mg

Just One Tablet!

Prevents & Relieves
Heartburn Due to
Acid Indigestion

25 Tablets

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-435
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-435-53	1 in 1 CARTON	04/26/2016
1		25 in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Fred's, Inc. (005866116)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(55315-435) , MANUFACTURE(55315-435)