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Famotidine - Acid Controller by WinCo Foods, LLC

Medically reviewed on December 11, 2017

Dosage form: tablet, film coated
Ingredients: FAMOTIDINE 10mg
Labeler: WinCo Foods, LLC
NDC Code: 67091-242

Drug Facts

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?

or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

PATIENT INFORMATION
 
JUST ONE TABLET prevents and relieves 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

Compare to the active ingredient in PepcidAC Original Strength

WinCo FOODS

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: WINCO FOODS, LLC, BOISE, ID 83704

5113374/0914

Principal Display Panel

Compare to the active ingredient in PepcidAC of Maximum Strength.

WinCo FOODS

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: WINCO FOODS, LLC, BOISE, ID 83704

5113376/0914

FAMOTIDINE - ACID CONTROLLER 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-242
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
STARCH, CORN 
MAGNESIUM STEARATE 
HYPROMELLOSES 
HYDROXYPROPYL CELLULOSE (TYPE H) 
TITANIUM DIOXIDE 
TALC 
POLYETHYLENE GLYCOL 400 
FERRIC OXIDE RED 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code035
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-242-3030 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028305/01/2012
FAMOTIDINE - ACID CONTROLLER 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-241
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code036
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-241-2525 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028305/01/2012
Labeler - WinCo Foods, LLC (056098817)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029MANUFACTURE(67091-241, 67091-242)

 
WinCo Foods, 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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