Famotidine Tablet, Film Coated

Manufacturer: TWIN MED LLC
Effective date: 2023-03-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:54:36

Label at a glance#

ProductFamotidine

Active ingredientFAMOTIDINE

Label structure11 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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking b...

Storage and handling

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 compares to the active ingredient in Zantac 360

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-844-912-4012

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP, 10 mg and 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

SPL UNCLASSIFIED SECTION

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

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 a doctor if

OTC - STOP USE SECTION

your heartburn continues or worsens
you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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

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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
- to prevent symptoms, swallow 1 tablet (of 20 mg) 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° - 25°C (68° - 77°F)
protect from moisture
compares to the active ingredient in Zantac 360

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol

Questions or comments?

OTC - QUESTIONS SECTION

Questions ? call toll-free 1-844-912-4012

SPL UNCLASSIFIED SECTION

Distributed by:
ProCure Products
Santa Fe Springs, CA 90670

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine 10 mg

originalFamotidine 20 mg

max

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199047	famotidine 10 MG Oral Tablet	PSN	1
310273	famotidine 20 MG Oral Tablet	PSN	1
199047	famotidine 10 MG Oral Tablet	SCD	1
310273	famotidine 20 MG Oral Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FAMOTIDINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae	Product name	7	20260317
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
cf645750-2e70-f6e1-c05a-a52847def5dd	Product name	9	20250312
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55681-341-03	Famotidine	300 in 1 BOTTLE	TABLET, FILM COATED	300		1
55681-342-03	Famotidine	300 in 1 BOTTLE	TABLET, FILM COATED	300		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55681-341	FAMOTIDINE TABLET, FILM COATED [TWIN MED LLC]	1	1 package rows	20230329_f7f1bb4e-df0d-8a7b-e053-6294a90a9c47.zip
55681-342	FAMOTIDINE TABLET, FILM COATED [TWIN MED LLC]	1	Current NDC, 1 package rows	20230329_f7f1bb4e-df0d-8a7b-e053-6294a90a9c47.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Famotidine
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A
HYDROXYPROPYL CELLULOSE (110000 WAMW)
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
TRIACETIN
POLYETHYLENE GLYCOL 4000
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55681-342	55681-342-03
55681-341	55681-341-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)	5Y0974F5PW	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
POLYETHYLENE GLYCOL 4000	4R4HFI6D95	IACT
TALC	7SEV7J4R1U	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)	5Y0974F5PW	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
POLYETHYLENE GLYCOL 4000	4R4HFI6D95	IACT
TALC	7SEV7J4R1U	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215822-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2022-01-28
A215822-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2022-01-28

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 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215822-001	FAMOTIDINE	10MG	TABLET / ORAL	2022-01-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215822-002	FAMOTIDINE	20MG	TABLET / ORAL	2022-01-28	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	TWIN MED LLC	6d97c60e-e39d-4541-ab49-d0fe3b3fa840	2026-06-16	Warnings	Exact identifier ndc (package): 55681-342-03 ndc (product): 55681-342 ndc11 (package): 55681034203
f7f1bb4e-df0e-8a7b-e053-6294a90a9c47			f7f1bb4e-df0d-8a7b-e053-6294a90a9c47	2023-03-18	Warnings	Exact identifier spl id: f7f1bb4e-df0e-8a7b-e053-6294a90a9c47 spl set id: f7f1bb4e-df0d-8a7b-e053-6294a90a9c47

Reported adverse events (FAERS/openFDA)#

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