Zantac 360

Manufacturer: Navajo Manufacturing Company Inc.
Effective date: 2024-04-15
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:11:06

Label at a glance#

ProductZantac 360

Active ingredientFAMOTIDINE

Label structure9 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#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-633-1610

Websitewww.zantacotc.com

www.zantacotc.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Zantac 360⁰

Famotidine Tablets 10 mg / Acid Reducer

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP 10 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

■ 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

SPL UNCLASSIFIED 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, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide

Questions or comments

OTC - QUESTIONS SECTION

call 1-800-633-1610 or visit www.zantacotc.com

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zantac 360 Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	2
2609246	Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022	PSN	2
2609246	famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]	SBD	2
310273	famotidine 20 MG Oral Tablet	SCD	2
2609246	Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022	SY	2
2609246	Zantac Reformulated Aug 2022 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
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67751-214-01	2024-04-15	C162847	48780-1	1030e365-0d27-111a-e063-dadaa90a10e2	Zantac 360
67751-214-02	2024-04-15	C162847	48780-1	1030e365-0d27-111a-e063-dadaa90a10e2	Zantac 360
67751-214-01	2024-01-30	C162847	48780-1	1030e365-0d27-111a-e063-dadaa90a10e2	Zantac 360
67751-214-02	2024-01-30	C162847	48780-1	1030e365-0d27-111a-e063-dadaa90a10e2	Zantac 360

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67751-214-01	Zantac 360	1 in 1 CARTON	TABLET, FILM COATED	1	2
67751-214-01	Zantac 360	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	2
67751-214-02	Zantac 360	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	2
67751-214-02	Zantac 360	2 in 1 CARTON	TABLET, FILM COATED	2	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-214	ZANTAC 360 (FAMOTIDINE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]	2	Current NDC, Legacy NDC, 4 package rows	20240417_e328c59c-baed-0e4e-e053-2995a90ab85c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41167-0361-0	EA - Each	41167-0361	b6b6fdf4-35ac-4a9a-b9df-a448e8fb2c6d	1	2021-08-05
41167-0361-2	EA - Each	41167-0361	dd5ca820-cc72-4c18-bc29-c5073e601762	1	2021-08-05
41167-0361-4	EA - Each	41167-0361	e31d00a7-f13f-472c-a6a7-5d6b637c5e01	1	2021-08-05
41167-0361-6	EA - Each	41167-0361	8ea2a35a-13dd-47d5-ae86-7189362d87d1	1	2021-08-05
41167-0361-8	EA - Each	41167-0361	d82c8712-128d-4bd3-afbb-92ea11ad6ccf	1	2021-08-05

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Zantac 360
Famotidine
CARNAUBA WAX
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
SODIUM STARCH GLYCOLATE TYPE A CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67751-214	67751-214-01, 67751-214-02
41167-0361

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARNAUBA WAX	R12CBM0EIZ	IACT
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	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
A206531-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2016-04-26
A206531-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2016-04-26

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206531-001	FAMOTIDINE	10MG	TABLET / ORAL	2016-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206531-002	FAMOTIDINE	20MG	TABLET / ORAL	2016-04-26	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zantac 360	FAMOTIDINE	Chattem, Inc.	89f60eb1-359b-40e8-ae8b-65aec9cd5b1f	2025-05-09	Warnings	Exact identifier ndc (product): 41167-0361
Zantac 360	FAMOTIDINE	Navajo Manufacturing Company Inc.	e328c59c-baed-0e4e-e053-2995a90ab85c	2024-04-15	Warnings	Exact identifier ndc (package): 67751-214-01 ndc (package): 67751-214-02 ndc (product): 67751-214 ndc11 (package): 67751021401 ndc11 (package): 67751021402 spl id: 16276432-35b8-25ca-e063-6394a90a0115 spl set id: e328c59c-baed-0e4e-e053-2995a90ab85c

Reported adverse events (FAERS/openFDA)#

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