Famotidine Tablets USP, 10 mg and 20 mg

Manufacturer
MARKSANS PHARMA LIMITED
Effective date
2024-09-30
Label type
Human OTC Drug Label
Version
5
Source
full-release
Hydrated at
2026-06-01 00:57:40

Label at a glance#

ProductFamotidine 10 mg
Active ingredientFamotidine
Label structure15 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

For 10 mg: • adults and children 12 years and over: o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. o to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn o do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor For 20 mg: • adults and children 12 years and ...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

For 10 mg:

Famotidine USP 10 mg


For 20 mg:

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

Directions

DOSAGE & ADMINISTRATION SECTION

For 10mg:

• adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
o do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor


For 20 mg:

• adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o 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
o do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

• 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

For 10 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide


For 20 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

Questions or comments?

SPL UNCLASSIFIED SECTION

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

Famotidine Tablets USP, 10 mg


NDC: 25000-086-36

Famotidine Tablets USP 10 mg

30's (3 x 10's blister) count Carton Label

famo-10mg-3x10s-blister-ifcfamo-10mg-3x10s-blister-ifc

 


NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Bottle Label

famo-10mg-30s-labelfamo-10mg-30s-label

 


NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Carton Label

famo-10mg-30s-ifcfamo-10mg-30s-ifc

 


NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Bottle Label

famo-10mg-100s-labelfamo-10mg-100s-label

 


NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Carton Label

famo-10mg-100s-ifcfamo-10mg-100s-ifc

 


Famotidine Tablets USP, 20 mg


NDC: 25000-087-36

Famotidine Tablets USP 20 mg

30's (3 x 10's blister) count Carton Label


famo-20mg-3x10s-blister-cartfamo-20mg-3x10s-blister-cart


NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Bottle Label

famo-20mg-30s-labelfamo-20mg-30s-label

 


NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Carton Label

famo-20mg-30s-ifcfamo-20mg-30s-ifc

 


NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Bottle Label

famo-20mg-100s-labelfamo-20mg-100s-label

 


NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Carton Label

famo-20mg-100s-ifcfamo-20mg-100s-ifc

 


NDC: 25000-087-82

Famotidine Tablets USP 20 mg

200's count Carton Label

famo-20mg-200s-cartonfamo-20mg-200s-carton

 


NDC: 25000-087-82

Famotidine Tablets USP 20 mg

200's count Bottle Label

famo-20mg-200s-labelfamo-20mg-200s-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199047famotidine 10 MG Oral TabletPSN5
310273famotidine 20 MG Oral TabletPSN5
199047famotidine 10 MG Oral TabletSCD5
310273famotidine 20 MG Oral TabletSCD5

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
25000-086-03Famotidine 10 mg30 in 1 BOTTLETABLET, COATED305
25000-086-03Famotidine 10 mg1 in 1 CARTONTABLET, COATED15
25000-086-07Famotidine 10 mg90 in 1 BOTTLETABLET, COATED905
25000-086-07Famotidine 10 mg1 in 1 CARTONTABLET, COATED15
25000-086-08Famotidine 10 mg100 in 1 BOTTLETABLET, COATED1005
25000-086-08Famotidine 10 mg1 in 1 CARTONTABLET, COATED15
25000-086-36Famotidine 10 mg10 in 1 BLISTER PACKTABLET, COATED105
25000-086-36Famotidine 10 mg3 in 1 CARTONTABLET, COATED35
25000-087-03Famotidine 20 mg30 in 1 BOTTLETABLET, COATED305
25000-087-03Famotidine 20 mg1 in 1 CARTONTABLET, COATED15
25000-087-05Famotidine 20 mg50 in 1 BOTTLETABLET, COATED505
25000-087-05Famotidine 20 mg1 in 1 CARTONTABLET, COATED15
25000-087-08Famotidine 20 mg1 in 1 CARTONTABLET, COATED15
25000-087-08Famotidine 20 mg100 in 1 BOTTLETABLET, COATED1005
25000-087-36Famotidine 20 mg3 in 1 CARTONTABLET, COATED35
25000-087-36Famotidine 20 mg10 in 1 BLISTER PACKTABLET, COATED105
25000-087-82Famotidine 20 mg1 in 1 CARTONTABLET, COATED15
25000-087-82Famotidine 20 mg200 in 1 BOTTLETABLET, COATED2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-086FAMOTIDINE 10 MG TABLET, COATED FAMOTIDINE 20 MG TABLET, COATED [MARKSANS PHARMA LIMITED]5Current NDC, 8 package rows20250325_58b653eb-6539-4b79-9d22-df6eaf35307f.zip
25000-087FAMOTIDINE 10 MG TABLET, COATED FAMOTIDINE 20 MG TABLET, COATED [MARKSANS PHARMA LIMITED]5Current NDC, 10 package rows20250325_58b653eb-6539-4b79-9d22-df6eaf35307f.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
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 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217543-001FAMOTIDINE10MGTABLET / 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…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217543-001FAMOTIDINE10MGTABLET / ORAL2023-03-08a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217543-002FAMOTIDINE20MGTABLET / ORAL2023-03-08a72a2bbeb626…

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 10 mgFAMOTIDINE 10 MGMARKSANS PHARMA LIMITED58b653eb-6539-4b79-9d22-df6eaf35307f2024-09-30WarningsExact identifier
ndc (package): 25000-086-03
ndc (package): 25000-087-82
ndc (package): 25000-086-07
ndc (package): 25000-087-05
ndc (package): 25000-086-36
ndc (package): 25000-086-08
ndc (package): 25000-087-36
ndc (package): 25000-087-08
ndc (package): 25000-087-03
ndc (product): 25000-086
ndc (product): 25000-087
ndc11 (package): 25000008736
ndc11 (package): 25000008603
ndc11 (package): 25000008708
ndc11 (package): 25000008608
ndc11 (package): 25000008705
ndc11 (package): 25000008703
ndc11 (package): 25000008607
ndc11 (package): 25000008782
ndc11 (package): 25000008636
spl id: c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402
spl set id: 58b653eb-6539-4b79-9d22-df6eaf35307f

Reported adverse events (FAERS/openFDA)#

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