Famotidine

Manufacturer
Sam's West Inc | Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited
Effective date
2021-12-24
Label type
Human OTC Drug Label
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:19:57

Label at a glance#

ProductFamotidine
Active ingredientFAMOTIDINE
Label structure17 sections

Indications and 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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION


Drug Facts

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


  • 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

OTC - ASK DOCTOR SECTION


  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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 (1-800-222-1222) right away.

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

STORAGE AND HANDLING SECTION


  • read the directions and warnings before use
  • 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


carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Questions or comments?

OTC - QUESTIONS SECTION


call 1-855-274-4122 Monday - Friday 8:30 AM to 5:00 PM EST

Tips for Managing Heartburn

  • 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

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Distributed by:
SAM’S WEST, INC.
BENTONVILLE, AR 72716

Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets, Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient
of Maximum Strength Pepcid® AC

M™

NDC 68196-225-21

see new warnings
maximum strength

famotidine
tablets USP, 20 mg
acid reducer

just one tablet prevents &
relieves heartburn due
to acid indigestion

100
Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets, Container Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (100 Tablets, Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (2x100 Tablets, Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the Active Ingredient
in Maximum Strength Pepcid® AC

see new warnings
NDC 68196-225-80

M Member's Mark™

maximum strength

famotidine
tablets USP, 20 mg
acid reducer

just one tablet prevents &
relieves heartburn due
to acid indigestion

Actual Size

200
Tablets
2x100
count
bottles



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (2x100 Tablets, Container Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (2x100 Tablets, Container Carton Label)

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68196-22568196-225-80

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

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.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206531-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2016-04-26
A206531-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2016-04-26

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2684e616aacf4f…
2026-09-14 22:38:342026-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2684e616aacf4f…
2026-08-18 06:07:402026-07A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2674a2ff9319b5…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e8edb2f8-f2b0-4db1-8650-533797ebb4739f658f49-ff8b-524f-e053-2995a90aee5c2022-10-29WarningsExact identifier
spl set id: 9f658f49-ff8b-524f-e053-2995a90aee5c

Reported adverse events (FAERS/openFDA)#

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