FDA.reportPublic FDA data

Zantac 360

Manufacturer
Chattem, Inc.
Effective date
2025-05-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:00:34

Label at a glance#

ProductZantac 360
Active ingredientFAMOTIDINE
Label structure19 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

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

Zantac 360⁰

Famotidine Tablets 20 mg / Acid Reducer

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP 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

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 1 0   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, yellow iron oxide

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
Famotidine Tablets USP 10 mg / Acid Reducer
360
30 Tablets

PRINCIPAL DISPLAY PANEL Zantac Famotidine Tablets USP 10 mg / Acid Reducer 360 30 TabletsPRINCIPAL DISPLAY PANEL Zantac Famotidine Tablets USP 10 mg / Acid Reducer 360 30 Tablets

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
Zantac
Famotidine Tablets USP 20 mg/Acid Reducer
360
100 TABLETS

MAXIMUM STRENGTH Zantac Famotidine Tablets USP 20 mg/Acid Reducer 360 100 TABLETSMAXIMUM STRENGTH Zantac Famotidine Tablets USP 20 mg/Acid Reducer 360 100 TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199047famotidine 10 MG Oral TabletPSN6
310273famotidine 20 MG Oral TabletPSN6
2607015Zantac 360 10 MG Oral Tablet, Reformulated Aug 2022PSN6
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022PSN6
2607015famotidine 10 MG Oral Tablet [Zantac Reformulated Aug 2022]SBD6
2609246famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]SBD6
199047famotidine 10 MG Oral TabletSCD6
310273famotidine 20 MG Oral TabletSCD6
2607015Zantac 360 10 MG Oral Tablet, Reformulated Aug 2022SY6
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022SY6
2607015Zantac Reformulated Aug 2022 10 MG Oral TabletSY6
2609246Zantac Reformulated Aug 2022 20 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FAMOTIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0360-2Zantac 36030 in 1 BOTTLETABLET, FILM COATED306
41167-0360-2Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-0Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-0Zantac 3608 in 1 BLISTER PACKTABLET, FILM COATED86
41167-0361-1Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-1Zantac 3601 in 1 BLISTER PACKTABLET, FILM COATED16
41167-0361-2Zantac 36025 in 1 BOTTLETABLET, FILM COATED256
41167-0361-2Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-4Zantac 36050 in 1 BOTTLETABLET, FILM COATED506
41167-0361-4Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-6Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-6Zantac 36090 in 1 BOTTLETABLET, FILM COATED906
41167-0361-8Zantac 3601 in 1 CARTONTABLET, FILM COATED16
41167-0361-8Zantac 360100 in 1 BOTTLETABLET, FILM COATED1006
41167-0361-9Zantac 36070 in 1 BOTTLETABLET, FILM COATED706
41167-0361-9Zantac 3602 in 1 CELLO PACKTABLET, FILM COATED26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0360ZANTAC 360 (FAMOTIDINE) TABLET, FILM COATED [CHATTEM, INC.]6Legacy NDC, 2 package rows20250508_89f60eb1-359b-40e8-ae8b-65aec9cd5b1f.zip
41167-0361ZANTAC 360 (FAMOTIDINE) TABLET, FILM COATED [CHATTEM, INC.]6Current NDC, Legacy NDC, 14 package rows20250508_89f60eb1-359b-40e8-ae8b-65aec9cd5b1f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0360-2EA - Each41167-036094174742-5173-45e9-8881-bdd5b44d6fce12021-08-05
41167-0361-0EA - Each41167-0361b6b6fdf4-35ac-4a9a-b9df-a448e8fb2c6d12021-08-05
41167-0361-2EA - Each41167-0361dd5ca820-cc72-4c18-bc29-c5073e60176212021-08-05
41167-0361-4EA - Each41167-0361e31d00a7-f13f-472c-a6a7-5d6b637c5e0112021-08-05
41167-0361-6EA - Each41167-03618ea2a35a-13dd-47d5-ae86-7189362d87d112021-08-05
41167-0361-8EA - Each41167-0361d82c8712-128d-4bd3-afbb-92ea11ad6ccf12021-08-05

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-036041167-0360-2
41167-036141167-0361-0, 41167-0361-2, 41167-0361-4, 41167-0361-9, 41167-0361-6, 41167-0361-8, 41167-0361-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
FAMOTIDINE5QZO15J2Z8ACTIB
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
FERRIC OXIDE RED1K09F3G675IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FAMOTIDINE5QZO15J2Z8ACTIB
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
FERRIC OXIDE RED1K09F3G675IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206531-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2016-04-26
A206531-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2016-04-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2684e616aacf4f…
2026-09-14 22:38:342026-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2684e616aacf4f…
2026-08-18 06:07:402026-07A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206531-001FAMOTIDINE10MGTABLET / ORAL2016-04-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206531-002FAMOTIDINE20MGTABLET / ORAL2016-04-2674a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zantac 360FAMOTIDINEChattem, Inc.89f60eb1-359b-40e8-ae8b-65aec9cd5b1f2025-05-09WarningsExact identifier
ndc (package): 41167-0361-8
ndc (package): 41167-0361-1
ndc (package): 41167-0361-4
ndc (package): 41167-0361-9
ndc (package): 41167-0360-2
ndc (package): 41167-0361-6
ndc (package): 41167-0361-2
ndc (package): 41167-0361-0
ndc (product): 41167-0361
ndc (product): 41167-0360
ndc11 (package): 41167036100
ndc11 (package): 41167036108
ndc11 (package): 41167036101
ndc11 (package): 41167036104
ndc11 (package): 41167036106
ndc11 (package): 41167036109
ndc11 (package): 41167036002
ndc11 (package): 41167036102
spl id: efcd0b2f-86c9-43c6-889f-7962e191a9cb
spl set id: 89f60eb1-359b-40e8-ae8b-65aec9cd5b1f

Reported adverse events (FAERS/openFDA)#

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