Famotidine

Manufacturer: Chain Drug Marketing Association INC
Effective date: 2025-07-17
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:07:46

Label at a glance#

ProductFamotidine

Active ingredientFAMOTIDINE

Label structure14 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 Famotidine 10 mg: 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 15 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 For Famotidine 20 mg: adults and children 12 ...

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 and light

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-375-3784

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP, 10 mg/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

SPL UNCLASSIFIED 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

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 Famotidine 10 mg:
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 15 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
For Famotidine 20 mg:
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°-25°C (68°-77°F)
protect from moisture and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, synthetic red iron oxide (only in 10 mg), talc and titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-375-3784

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine 10 mg

Container Label

Famotidine 10 mg Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine 10 mg Container Carton Label

Famotidine 10 mg Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine 20 mg

Container Label

Famotidine 20 mg Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine 20 mg Container Carton LabelFamotidine 20 mg Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199047	famotidine 10 MG Oral Tablet	PSN	6
310273	famotidine 20 MG Oral Tablet	PSN	6
199047	famotidine 10 MG Oral Tablet	SCD	6
310273	famotidine 20 MG Oral Tablet	SCD	6

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	SPL version
63868-583-30	Famotidine	1 in 1 CARTON	TABLET	1	6
63868-583-30	Famotidine	30 in 1 BOTTLE	TABLET	30	6
63868-584-25	Famotidine	1 in 1 CARTON	TABLET	1	6
63868-584-25	Famotidine	25 in 1 BOTTLE	TABLET	25	6
63868-584-50	Famotidine	1 in 1 CARTON	TABLET	1	6
63868-584-50	Famotidine	50 in 1 BOTTLE	TABLET	50	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-583-30	EA - Each	63868-583	63dea84e-282f-46c1-9990-b226bda79ecd	1	2022-10-06
55111-118-90	EA - Each	55111-118	b0358378-0ed2-4912-b058-89e7e6d918f7	1	2021-04-08
63868-584-25	EA - Each	63868-584	59f6ee3d-2a4d-45ae-a676-071b3166647b	1	2022-10-06
63868-584-50	EA - Each	63868-584	7f6c9b1f-cafe-4812-b26a-708134c60483	1	2022-10-06
55111-396-01	EA - Each	55111-396	014c7729-02a3-4e5b-946d-9e53c2af174b	1	2021-04-08

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Famotidine
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
HYPROMELLOSES
STARCH, CORN
Polyethylene Glycol, Unspecified
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-583	63868-583-30
55111-118
63868-584	63868-584-25, 63868-584-50
55111-396

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FAMOTIDINE	5QZO15J2Z8	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
STARCH, CORN	O8232NY3SJ	IACT
Polyethylene Glycol, Unspecified	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
STARCH, CORN	O8232NY3SJ	IACT
Polyethylene Glycol, Unspecified	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

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
A077367-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2006-09-25
A077367-002	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2001-08-17

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 · 82 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	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`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	Chain Drug Marketing Association INC	1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a	2025-07-17	Warnings	Exact identifier ndc (package): 63868-583-30 ndc (package): 63868-584-50 ndc (package): 63868-584-25 ndc (product): 63868-584 ndc (product): 63868-583 ndc11 (package): 63868058330 ndc11 (package): 63868058450 ndc11 (package): 63868058425 spl id: cf8df4a2-be86-9900-a859-a08b841f6a53 spl set id: 1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a
Famotidine	FAMOTIDINE	Dr.Reddys Laboratories Limited	387088a6-8eaa-fc49-8050-a546d0f0fd32	2025-06-03	Warnings	Exact identifier ndc (product): 55111-396 ndc (product): 55111-118

Reported adverse events (FAERS/openFDA)#

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