Famotidine Tablets USP, 20 mg - Cool Mint Flavor

Manufacturer
MARKSANS PHARMA LIMITED
Effective date
2025-05-06
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 01:01:29

Label at a glance#

ProductFamotidine 20 mg
Active ingredientFAMOTIDINE
Label structure15 sections

Dosage and administration

Directions •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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Famotidine USP 20 mg

PURPOSE

OTC - PURPOSE SECTION

Purpose 
Acid reducer

USE(S)

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

Warnings

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

DO NOT USE

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

ASK A DOCTOR BEFORE USE IF

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
•kidney disease  

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

STOP USE AND ASK DOCTOR IF

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

PREGNANCY/BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN

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

Directions
•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

Other information
•read the directions and warnings before use
•keep the carton. It contains important information.
•store at 20°-25°C (68°-77°F)
•protect from moisture
•Meets USP dissolution test 2

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium saccharin, talc, titanium dioxide

QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)


•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
•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


Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA


Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India 

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC: 25000-124-94
Famotidine Tablets USP 20 mg- Cool mint flavor
25's (5 x 5's blister) count Carton Label

famotidine-20mg-5x5s-cool-mint-blister-ifcfamotidine-20mg-5x5s-cool-mint-blister-ifc


NDC: 25000-124-84
Famotidine Tablets USP 20 mg- Cool mint flavor
25's count Bottle Label

 

famotidine-20mg-25s-cool-mint-label
famotidine-20mg-25s-cool-mint-label

NDC: 25000-124-84
Famotidine Tablets USP 20 mg- Cool mint flavor
25's count Carton Label

famotidine-20mg-25s-cool-mint-ifcfamotidine-20mg-25s-cool-mint-ifc




NDC: 25000-124-68
Famotidine Tablets USP 20 mg- Cool mint flavor
300's count Bottle Label

famotidine-20mg-300s-cool-mint-label
famotidine-20mg-300s-cool-mint-label



DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310273famotidine 20 MG Oral TabletPSN2
310273famotidine 20 MG Oral TabletSCD2

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
25000-124-68Famotidine 20 mg300 in 1 BOTTLETABLET, COATED3002
25000-124-84Famotidine 20 mg1 in 1 CARTONTABLET, COATED12
25000-124-84Famotidine 20 mg25 in 1 BOTTLETABLET, COATED252
25000-124-94Famotidine 20 mg5 in 1 BLISTER PACKTABLET, COATED52
25000-124-94Famotidine 20 mg5 in 1 CARTONTABLET, COATED52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-124FAMOTIDINE 20 MG TABLET, COATED [MARKSANS PHARMA LIMITED]2Current NDC, 5 package rows20250524_5a66206b-35b1-4d86-8574-a1e45cb0772f.zip

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
25000-12425000-124-94, 25000-124-84, 25000-124-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 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
A217543-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2023-03-08
A217543-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2023-03-08

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 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08c2088c7a36db…
2026-10-15 13:18:302026-09A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08c2088c7a36db…
2026-09-14 22:38:342026-08A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-0884e616aacf4f…
2026-09-14 22:38:342026-08A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-0884e616aacf4f…
2026-08-18 06:07:402026-07A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-088072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-086a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-081c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08ea1830bbd6c7…

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
Famotidine 20 mgFAMOTIDINE 20 MGMARKSANS PHARMA LIMITED5a66206b-35b1-4d86-8574-a1e45cb0772f2025-05-06WarningsExact identifier
ndc (package): 25000-124-94
ndc (package): 25000-124-84
ndc (package): 25000-124-68
ndc (product): 25000-124
ndc11 (package): 25000012468
ndc11 (package): 25000012494
ndc11 (package): 25000012484
spl id: 1c69fac1-3052-45b1-ab46-a3b523347de1
spl set id: 5a66206b-35b1-4d86-8574-a1e45cb0772f

Reported adverse events (FAERS/openFDA)#

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