Famotidine

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited
Effective date
2025-04-22
Label type
Human OTC Drug Label
Version
14
Source
full-release
Hydrated at
2026-06-01 00:59:38

Label at a glance#

ProductFamotidine
Active ingredientFAMOTIDINE
Label structure18 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

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:
AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
NDC 58602-706-14

MAXIMUM STRENGTH
Famotidine
Tablets USP 20 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

50 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


AUROHEALTH

NDC 58602-706-14
*Compare to the Active Ingredient
of Maximum Strength Pepcid® AC
MAXIMUM STRENGTH

Famotidine
Tablets USP
20 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

50 Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Carton Label)





PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg Blister Carton 25 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


AUROHEALTH

NDC 58602-706-62
*Compare to the Active
Ingredient of Maximum
Strength Pepcid® AC
MAXIMUM STRENGTH
Famotidine
Tablets USP
20 mg

Acid Reducer
Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

25 Tablets

famotidine-20mg-fig3.jpgfamotidine-20mg-fig3.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310273famotidine 20 MG Oral TabletPSN14
310273famotidine 20 MG Oral TabletSCD14

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FAMOTIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-706-14Famotidine50 in 1 BOTTLETABLET, FILM COATED5014
58602-706-14Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-15Famotidine8 in 1 BLISTER PACKTABLET, FILM COATED814
58602-706-15Famotidine2 in 1 CARTONTABLET, FILM COATED214
58602-706-16Famotidine65 in 1 BOTTLETABLET, FILM COATED6514
58602-706-16Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-18Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-18Famotidine80 in 1 BOTTLETABLET, FILM COATED8014
58602-706-19Famotidine90 in 1 BOTTLETABLET, FILM COATED9014
58602-706-19Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-21Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-21Famotidine100 in 1 BOTTLETABLET, FILM COATED10014
58602-706-34Famotidine200 in 1 BOTTLETABLET, FILM COATED20014
58602-706-34Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-39Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-39Famotidine365 in 1 BOTTLETABLET, FILM COATED36514
58602-706-40Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-40Famotidine500 in 1 BOTTLETABLET, FILM COATED50014
58602-706-41Famotidine1000 in 1 BOTTLETABLET, FILM COATED100014
58602-706-44Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-44Famotidine400 in 1 BOTTLETABLET, FILM COATED40014
58602-706-47Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-47Famotidine75 in 1 BOTTLETABLET, FILM COATED7514
58602-706-50Famotidine85 in 1 BOTTLETABLET, FILM COATED8514
58602-706-50Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-53Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-53Famotidine25 in 1 BOTTLETABLET, FILM COATED2514
58602-706-54Famotidine70 in 1 BOTTLETABLET, FILM COATED7014
58602-706-54Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-56Famotidine35 in 1 BOTTLETABLET, FILM COATED3514
58602-706-56Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-60Famotidine5 in 1 BLISTER PACKTABLET, FILM COATED514
58602-706-62Famotidine5 in 1 CARTONTABLET, FILM COATED514
58602-706-79Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-79Famotidine8 in 1 BLISTER PACKTABLET, FILM COATED814
58602-706-88Famotidine750 in 1 BOTTLETABLET, FILM COATED75014
58602-706-94Famotidine100 in 1 BOTTLETABLET, FILM COATED10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-706FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC]14Current NDC, Legacy NDC, 37 package rows20250425_f2b911c7-ce24-4d3d-8fb6-c34980191f40.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-706-53EA - Each58602-706467d38ee-c6d2-45ee-acf3-41c19f75ab5912020-03-10

Products#

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

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

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 · Source PDF

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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26c2088c7a36db…
2026-10-15 13:18:302026-09A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26c2088c7a36db…
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…

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
FamotidineFAMOTIDINEAurohealth LLCf2b911c7-ce24-4d3d-8fb6-c34980191f402025-04-22WarningsExact identifier
ndc (package): 58602-706-41
ndc (package): 58602-706-79
ndc (package): 58602-706-94
ndc (package): 58602-706-19
ndc (package): 58602-706-39
ndc (package): 58602-706-14
ndc (package): 58602-706-88
ndc (package): 58602-706-47
ndc (package): 58602-706-53
ndc (package): 58602-706-18
ndc (package): 58602-706-54
ndc (package): 58602-706-44
ndc (package): 58602-706-40
ndc (package): 58602-706-16
ndc (package): 58602-706-60
ndc (package): 58602-706-15
ndc (package): 58602-706-50
ndc (package): 58602-706-56
ndc (package): 58602-706-21
ndc (package): 58602-706-62
ndc (package): 58602-706-34
ndc (product): 58602-706
ndc11 (package): 58602070616
ndc11 (package): 58602070618
ndc11 (package): 58602070650
ndc11 (package): 58602070640
ndc11 (package): 58602070621
ndc11 (package): 58602070647
ndc11 (package): 58602070694
ndc11 (package): 58602070615
ndc11 (package): 58602070688
ndc11 (package): 58602070619
ndc11 (package): 58602070654
ndc11 (package): 58602070656
ndc11 (package): 58602070641
ndc11 (package): 58602070634
ndc11 (package): 58602070660
ndc11 (package): 58602070679
ndc11 (package): 58602070644
ndc11 (package): 58602070662
ndc11 (package): 58602070614
ndc11 (package): 58602070639
ndc11 (package): 58602070653
spl id: 4329025b-5cdd-4287-955f-028e6aca198c
spl set id: f2b911c7-ce24-4d3d-8fb6-c34980191f40

Reported adverse events (FAERS/openFDA)#

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