Famotidine

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Famotidine, USP 20 mg

PURPOSE

OTC - PURPOSE SECTION

Acid reducer

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - STOP USE SECTION

• your heartburn continues or worsens
• you need to take this product for more than 14 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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 PRINTED FOIL UNDER CAP IS OPEN OR TORN

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PATIENT INFORMATION

PATIENT MEDICATION INFORMATION SECTION

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

SPL UNCLASSIFIED SECTION

• 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 - 20 mg Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Maximum Strength
Pepcid AC^® active ingredient^††

NDC 0363-0036-26

Acid Controller
FAMOTIDINE TABLETS, USP 20 mg
ACID REDUCER

NEW
LOOK
SAME GREAT
QUALITY

MAXIMUM STRENGTH

• Just one tablet prevents & relieves
  heartburn due to acid indigestion

25 TABLETS

ACTUAL SIZE

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

• Famotidine
• SILICON DIOXIDE
• HYDROXYPROPYL CELLULOSE (1200000 MW)
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POLYETHYLENE GLYCOL 400
• STARCH, CORN
• TALC
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 303 matching rows.

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.