Famotidine

Manufacturer: LEADER/ Cardinal Health 110, Inc.
Effective date: 2025-02-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:54:54

Label at a glance#

ProductFamotidine

Active ingredientFAMOTIDINE

Label structure10 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 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

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-231-4670

PhoneLabel contact1-800-200-6313

Websitewww.myleader.com

www.myleader.com

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(in each tablet)
Famotidine 20 mg

OTC - PURPOSE SECTION

Purpose
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 SECTION

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

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

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

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
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.

OVERDOSAGE SECTION

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 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

Other information

OTHER SAFETY INFORMATION

read the directions and warnings before use
store at 20°-25°C (68°-77°F)
protect from moisture
meets USP Dissolution Test 2

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide.

OTC - QUESTIONS SECTION

Questions or comments?

1-800-231-4670:
weekdays 9am-5pm EST

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Pepcid AC®.

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0710-1

Maximum Strength

Acid Reducer

Famotidine Tablets USP, 20 mg

Just One Tablet Prevents
& Relieves Heartburn Due
to Acid Indigestion

COMPARE TO MAXIMUM STRENGTH PEPCID AC® active ingredient*

200
TABLETS

Leader Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	2
310273	famotidine 20 MG Oral Tablet	SCD	2

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
70000-0710-1	Famotidine	200 in 1 BOTTLE	TABLET, FILM COATED	200		2
70000-0710-1	Famotidine	1 in 1 CARTON	TABLET, FILM COATED	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0710	FAMOTIDINE TABLET, FILM COATED [LEADER/ CARDINAL HEALTH 110, INC.]	2	Current NDC, 2 package rows	20250213_287525d8-83ef-7110-e063-6294a90ad373.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0710-1	EA - Each	70000-0710	947149c1-abb6-4f91-abe4-50a08b3f56ab	1	2025-12-16

Products#

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

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

Famotidine
POLYETHYLENE GLYCOL 400
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
STARCH, CORN
TITANIUM DIOXIDE
TALC
SODIUM STARCH GLYCOLATE TYPE A
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70000-0710	70000-0710-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
STARCH, CORN	O8232NY3SJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TALC	7SEV7J4R1U	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	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
A218003-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2024-05-28
A218003-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2024-05-28

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.

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	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218003-001	FAMOTIDINE	10MG	TABLET / ORAL	2024-05-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218003-002	FAMOTIDINE	20MG	TABLET / ORAL	2024-05-28	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	LEADER/ Cardinal Health 110, Inc.	287525d8-83ef-7110-e063-6294a90ad373	2025-02-11	Warnings	Exact identifier ndc (package): 70000-0710-1 ndc (product): 70000-0710 ndc11 (package): 70000071001 spl id: 2de46de3-c99e-22ea-e063-6394a90a165d spl set id: 287525d8-83ef-7110-e063-6294a90ad373

Reported adverse events (FAERS/openFDA)#

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