Famotidine Tablets USP 10 mg ACID REDUCER

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine, USP 10 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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional
before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 anytime 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

STORAGE AND HANDLING SECTION

• read the directions and warnings before use
• TAMPER-EVIDENT: Do not use this product if carton has
  been opened, if blister backing appears to have been
  disturbed, or if individual blister units are broken or torn.
• keep the carton. It contains important information.
• store at 20° to 25°C (68° to 77°F)
• protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C Red #40 aluminum lake,
FD&C Yellow #6 aluminum lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol,
pregelatinized starch, sodium starch glycolate, talc,
titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call 1-888-838-2872, weekdays, 8 AM to 5 PM Eastern Time

Principal Display Panel, Part 1 of 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel, Part 2 of 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP 10 mg Acid Reducer, Just One Per Dose, 30s Carton Text

SPL UNCLASSIFIED SECTION

Prevents and Relieves Heartburn Due to Acid Indigestion

NDC 0093-2748-65

Tamper-Evident

Famotidine

Tablets USP

10 mg

ACID REDUCER

30 TABLETS Just One Per Dose

TEVA

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

• Famotidine
• SILICON DIOXIDE
• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• STARCH, CORN
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• TALC
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 · 304 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 · 1 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 2 · 44 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.