leader acid reducer

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 10 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

1. relieves heartburn associated with acid indigestion and sour stomach
2. 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

1. 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.
2. with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

1. had heartburn over 3 months. This may be a sign of a more serious condition.
2. heartburn with lightheadedness, sweating, or dizziness
3. chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
4. frequent chest pain
5. frequent wheezing, particularly with heartburn
6. unexplained weight loss
7. nausea or vomiting
8. stomach pain

Stop use and ask a doctor if

OTC - STOP USE SECTION

1. your heartburn continues or worsens
2. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

1. adults and children 12 years and over:
2. to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
3. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn
4. do not use more than 2 tablets in 24 hours
5. children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

1. read the directions and warnings before use
2. keep the carton. It contains important information.
3. store at 20°-25°C (68°-77°F)
4. protect from moisture and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Original Strength Pepcid® AC active ingredient

Original Strength

Famotidine Tablets, 10 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Actual Size

Acid Reducer Carton Image 2

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

• leader acid reducer original strength
• Famotidine
• CARNAUBA WAX
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• STARCH, CORN
• POLYDEXTROSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• TALC
• TITANIUM DIOXIDE
• TRIACETIN
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 5 · 260 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.