Pepcid AC

Manufacturer: Lil' Drug Store Products, Inc.
Effective date: 2024-01-09
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:06:53

Label at a glance#

ProductPepcid AC

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 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

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-755-4008

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 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 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-755-4008 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA

Repackaged and distributed by:
Lil' Drug Store Products, Inc., 9300 Earhart Lane SW
Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine Tablets 20 mg
Acid Reducer

Just One Tablet!
Prevents & Relieves Heartburn
Due to Acid Indigestion

[tablet image]

5
Tablets

[Lil' Drug Store® logo]

PDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	7
104094	Pepcid AC 20 MG Oral Tablet	PSN	7
104094	famotidine 20 MG Oral Tablet [Pepcid]	SBD	7
310273	famotidine 20 MG Oral Tablet	SCD	7
104094	Pepcid 20 MG Oral Tablet	SY	7
104094	Pepcid AC 20 MG Oral Tablet	SY	7

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	Strength	SPL version
66715-9748-8	Pepcid AC	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		7
66715-9748-8	Pepcid AC	5 in 1 CARTON	TABLET, FILM COATED	5		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66715-9748	PEPCID AC (FAMOTIDINE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20240110_14406cd8-468b-403d-9be2-43decd304214.zip

Products#

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

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

Pepcid AC
Famotidine
CARNAUBA WAX
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66715-9748	66715-9748-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARNAUBA WAX	R12CBM0EIZ	IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)	UKE75GEA7F	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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
N020325-001	PEPCID AC	FAMOTIDINE	10MG	TABLET / ORAL		RLD	1995-04-28
N020325-002	PEPCID AC	FAMOTIDINE	20MG	TABLET / ORAL		RLD, RS	2003-09-23

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`74a2ff9319b5…`

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
Pepcid AC	FAMOTIDINE	Lil' Drug Store Products, Inc.	14406cd8-468b-403d-9be2-43decd304214	2024-01-09	Warnings	Exact identifier ndc (package): 66715-9748-8 ndc (product): 66715-9748 ndc11 (package): 66715974808 spl id: 0e8487fc-3e0e-bbfc-e063-6394a90a3073 spl set id: 14406cd8-468b-403d-9be2-43decd304214

Reported adverse events (FAERS/openFDA)#

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