Safeway Inc. Maximum Strength 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

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.

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°-25°C (68°-77°F)
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?

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Compare to Maximum Strength Pepcid® AC active ingredient

Maximum Strength

Acid Controller

Famotidine Tablets, 20 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Actual Size

Maximum Strength Acid Controller Carton Image 1

Maximum Strength Acid Controller Carton Image 2

ACID CONTROLLER MAXIMUM STRENGTH
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:21130-194
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FAMOTIDINE (FAMOTIDINE)	FAMOTIDINE	20 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	8mm
Flavor		Imprint Code	L194
Contains

#	Item Code	Package Description
Packaging
1	NDC:21130-194-71	1 in 1 CARTON
1		50 in 1 BOTTLE
2	NDC:21130-194-02	5 in 1 CARTON
2		5 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077351	06/15/2007

Labeler - Safeway (009137209)

Revised: 7/2009

Document Id: 4adf1ee3-3758-4d56-880d-1c06ca9543ae

Set id: 4adf1ee3-3758-4d56-880d-1c06ca9543ae

Version: 1

Effective Time: 20090727

Safeway