OTC Medication Information: Acid Controller Original Strength

ACID CONTROLLER ORIGINAL STRENGTH- famotidine tablet, film coated
CVS Pharmacy

Active ingredient (in each tablet)

Famotidine 10 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.
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
kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers 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 15 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

Inactive ingredients

carnauba wax, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Pepcid® AC

Original Strength

Acid Controller

FAMOTIDINE TABLETS, 10 mg

Acid reducer

Just one tablet:

Prevents & relieves heartburn due to acid indigestion

SEE NEW WARNINGS

Actual Size

30 TABLETS

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ACID CONTROLLER ORIGINAL STRENGTH
famotidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L141
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-141-60 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (59779-141-60)
2 NDC:59779-141-72 1 BOTTLE in 1 CARTON contains a BOTTLE
2 60 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (59779-141-72)
3 NDC:59779-141-75 1 BOTTLE in 1 CARTON contains a BOTTLE
3 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (59779-141-75)
4 NDC:59779-141-39 1 BOTTLE in 1 CARTON contains a BOTTLE
4 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (59779-141-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075400 10/17/2009
Labeler — CVS Pharmacy (062312574)

Revised: 07/2021 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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