Maximum Strength PEPCID AC

Manufacturer: Kenvue Brands LLC
Effective date: 2024-11-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:36:45

Label at a glance#

ProductMaximum Strength PEPCID AC Icy Cool Mint

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, FD&C blue no. 1 aluminum lake, flavors, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sucralose, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

USER SAFETY WARNINGS SECTION

Do not use if foil inner seal imprinted with SEALED FOR YOUR SAFETY is broken or missing

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16837-889-40

MAXIMUM STRENGTH

Pepcid _®

Famotidine Tablets 20 mg

Acid Reducer

ICY COOL MINT

Flavored Coating

Just One Tablet!

Prevents & Relieves Heartburn

Due to Acid Indigestion

actual size

40 Tablets

pepcid-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	2
104094	Pepcid AC 20 MG Oral Tablet	PSN	2
104094	famotidine 20 MG Oral Tablet [Pepcid]	SBD	2
310273	famotidine 20 MG Oral Tablet	SCD	2
104094	Pepcid 20 MG Oral Tablet	SY	2
104094	Pepcid AC 20 MG Oral Tablet	SY	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
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
16837-889-20	Maximum Strength PEPCID ACIcy Cool Mint	1 in 1 CARTON	TABLET, FILM COATED	1	2
16837-889-20	Maximum Strength PEPCID ACIcy Cool Mint	20 in 1 BOTTLE	TABLET, FILM COATED	20	2
16837-889-40	Maximum Strength PEPCID ACIcy Cool Mint	40 in 1 BOTTLE	TABLET, FILM COATED	40	2
16837-889-40	Maximum Strength PEPCID ACIcy Cool Mint	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
16837-889	MAXIMUM STRENGTH PEPCID AC ICY COOL MINT (FAMOTIDINE) TABLET, FILM COATED [KENVUE BRANDS LLC]	2	Current NDC, 4 package rows	20241114_0f343092-4fc7-1fff-e063-6294a90aba6e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Maximum Strength PEPCID AC Icy Cool Mint
Famotidine
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CARNAUBA WAX
SUCRALOSE
FD&C BLUE NO. 1 ALUMINUM LAKE
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16837-889	16837-889-20, 16837-889-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB
SUCRALOSE	96K6UQ3ZD4	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYSORBATE 80	6OZP39ZG8H	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
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
Maximum Strength PEPCID AC Icy Cool Mint	FAMOTIDINE	Kenvue Brands LLC	0f343092-4fc7-1fff-e063-6294a90aba6e	2024-11-11	Warnings	Exact identifier ndc (package): 16837-889-20 ndc (package): 16837-889-40 ndc (product): 16837-889 ndc11 (package): 16837088940 ndc11 (package): 16837088920 spl id: 21af4ff4-5892-565e-e063-6394a90aa728 spl set id: 0f343092-4fc7-1fff-e063-6294a90aba6e

Reported adverse events (FAERS/openFDA)#

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