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ACID CONTROLLER by International Laboratories, LLC

Medically reviewed on April 6, 2017

Dosage form: tablet
Ingredients: FAMOTIDINE 20mg
Labeler: International Laboratories, LLC
NDC Code: 54458-851

International Laboratories, Inc. Acid Controller Drug Facts

Active ingredient (in each tablet)

 Famotidine 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

Ask a doctor or pharmacist before use if you are
  • presently taking a prescription drug.  Antacids may interact with certain prescription drugs.

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

• read the directions and warnings before use
• store at 20º-25ºC (68º-77ºF)
• protect from moisture and light

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide

Questions or comments?

 1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

Famotidine ECL

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Maximum Strength Pepcid® AC

MAXIMUM STRENGTH

Acid Controller

FAMOTIDINE TABLETS, 20 mg

Acid reducer

Just one tablet:

Prevents & relieves heartburn due to acid indigestion

14 TABLETS

Actual Size

LIFT HERE TO OPEN

Famotidine

 

ACID CONTROLLER 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54458-851(NDC:59779-194)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYVINYL ALCOHOL, UNSPECIFIED 
TALC 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeL194
Contains    
Packaging
#Item CodePackage Description
1NDC:54458-851-1414 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735105/27/2016
Labeler - International Laboratories, LLC (023569924)
Establishment
NameAddressID/FEIOperations
L. Perrigo Company078716293MANUFACTURE(54458-851), RELABEL(54458-851), REPACK(54458-851)
Establishment
NameAddressID/FEIOperations
L. Perrigo Company006013346MANUFACTURE(54458-851), RELABEL(54458-851), REPACK(54458-851)

 
International Laboratories, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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