FAMOTIDINE - ACID CONTROLLER- famotidine tablet, film coated 
Ohm Laboratories Inc.

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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 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.

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 to60 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, 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

  • 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

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. (In Blister Carton)

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (In Bottle Carton)

TAMPER EVIDENT: DO NOT USE IF PRINTED FOIL UNDER CAP IS OPEN OR TORN. (In Stand-Alone Label)

See end panel for batch number and expiration date.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue,

North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL

ohm®

NDC51660-035-31

ORIGINALSTRENGTH

AcidController

Famotidine Tablets USP, 10 mg

Acid Reducer

Just One Tablet

Prevents&Relieves Heartburn Due to Acid Indigestion

30TABLETS

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

This product is not manufactured or distributed by Johnson & JohnsonMerck Consumer Pharmaceuticals Co., distributor of Pepcid®AC. Pepcid®AC is a registered trademark of Merck & Co., Inc.

This is the 30 count bottle carton label for Famotidine tablets USP, 10 mg.

ohm®

NDC51660-036-50

MAXIMUMSTRENGTH

AcidController

Famotidine Tablets USP, 20 mg

Acid Reducer

Just One Tablet

Prevents&Relieves Heartburn Due to Acid Indigestion

50TABLETS

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

This product is not manufactured or distributed by Johnson & Johnson Merck Consumer Pharmaceuticals Co., distributor of Pepcid®AC. Pepcid®AC is a registered trademark of Merck & Co., Inc.

This is the 50 count bottle carton label for Famotidine tablets USP, 20 mg.
This is the 30 count bottle carton label for Kinray Famotidine tablets USP, 10 mg

Private Label Distributor - Kinray 10 mg - 30s

This is the 25 count bottle carton label for Kinray Famotidine tablets USP, 20 mg

Private Label Distributor - Kinray 20 mg - 25s

FAMOTIDINE - ACID CONTROLLER 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-036
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 036
Contains    
Packaging
#Item CodePackage Description
1NDC:51660-036-2325 in 1 BOTTLE
2NDC:51660-036-5050 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028307/23/2010
FAMOTIDINE - ACID CONTROLLER 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-035
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, PREGELATINIZED CORN 
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
HYPROMELLOSES 
HYDROXYPROPYL CELLULOSE 
TITANIUM DIOXIDE 
TALC 
POLYETHYLENE GLYCOL 400 
FERRIC OXIDE RED 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 035
Contains    
Packaging
#Item CodePackage Description
1NDC:51660-035-3130 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028306/25/2010
Labeler - Ohm Laboratories Inc. (184769029)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture

Revised: 06/2012
 
Ohm Laboratories Inc.