FAMOTIDINE tablet, film coated

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by Kinray, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH TABLET)

Famotidine USP, 10 mg

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

Famotidine USP, 10 mg

• with other acid reducers
• 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.

Famotidine USP, 20 mg

• 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

Famotidine USP, 10 mg

• 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 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

Famotidine USP, 20 mg

• 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.
• TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
• TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.

INACTIVE INGREDIENTS

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (only for Famotidine USP, 10 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PATIENT INFORMATION

• 1 tablet relieves heartburn due to acid indigestion
• Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

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

PRINCIPAL DISPLAY PANEL

Preferred Plus Pharmacy™

†Compare to the active ingredient of Original Strength Pepcid® AC

ORIGINAL STRENGTH

Acid Controller

Famotidine Tablets USP, 10 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

30 Tablets

Distributed By: Kinray, Inc.

5086088/0411

Preferred Plus Pharmacy™

†Compare to the active ingredient of Maximum Strength Pepcid®AC

MAXIMUM STRENGTH

Acid Controller

Famotidine Tablets USP, 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

25 Tablets

Distributed By: Kinray, Inc.

5091314/1111

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-063
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STARCH, PREGELATINIZED 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-063-30	1 in 1 CARTON
1		30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090283	10/03/2011

FAMOTIDINE 
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-064
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
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-064-25	1 in 1 CARTON
1		25 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090283	02/15/2012

Labeler - Kinray (012574513)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	manufacture(61715-063, 61715-064)