FDA.reportPublic FDA data

Zantac 360

Manufacturer
Lil' Drug Store Products, Inc
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:33

Label at a glance#

ProductZantac 360
Active ingredientFAMOTIDINE
Label structure12 sections

Indications and uses

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 foods and beverages

Dosage and administration

Directions 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Famotidine USP 20 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Acid reducer

Uses

INDICATIONS & USAGE SECTION

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 foods and beverages

Warnings

WARNINGS SECTION

Alergy alert

SPL UNCLASSIFIED SECTION

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

Do not use

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

Ask a doctor before use

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

Ask a doctor or pharmacist

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 healthcare 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

Directions

  • 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

SPL UNCLASSIFIED SECTION

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20º-25ºC (68º-77ºF)
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
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

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

SPL UNCLASSIFIED SECTION

Product manufactured for:
Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219
©2021 Made in India

Product repackaged and distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW, Cedar Rapids, IA 52404
1-877-507-6516 (M-F 8AM-4:30PM CST)
www.lildrugstore.com 97585C-US-04-21

PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA MAXIMUM STRENGTH
See New Warnings

Zantac

360°™

Famotidine Tablets USP 20 mg / Acid Reducer

JUST ONE TABLET

PREVENTS
& RELIEVES
HEARTBURN

DUE TO ACID
INDIGESTION

[tablet image]

Actual Size

5 Tablets

(5 Doses)

[Lil' Drug Store logo]

PDPPDP

Zantac 360°™, Lil' Drug Store ® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA MAXIMUM STRENGTH
See New Warnings

Zantac

360°™

Famotidine Tablets USP 20 mg / Acid Reducer

JUST ONE TABLET

PREVENTS
& RELIEVES
HEARTBURN

DUE TO ACID
INDIGESTION

[tablet image]

Actual Size

2 Tablets

(2 Doses)

[Lil' Drug Store logo]

PDP/PackagePDP/Package

Zantac 360°™, Travel BASIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA
See New Warnings

MAXIMUM STRENGTH

Zantac

360°™

Famotidine Tablets USP 20 mg / Acid Reducer

JUST ONE TABLET

PREVENTS
& RELIEVES
HEARTBURN

DUE TO ACID
INDIGESTION

[tablet image]

Actual Size

2 Tablets

[Travel BASIX logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310273famotidine 20 MG Oral TabletPSN3
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022PSN3
2609246famotidine 20 MG Oral Tablet [Zantac Reformulated Aug 2022]SBD3
310273famotidine 20 MG Oral TabletSCD3
2609246Zantac 360 20 MG Oral Tablet, Reformulated Aug 2022SY3
2609246Zantac Reformulated Aug 2022 20 MG Oral TabletSY3

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
66715-6458-2Zantac 360, Travel BASIX1 in 1 CARTONTABLET, FILM COATED13
66715-6458-2Zantac 360, Travel BASIX2 in 1 BLISTER PACKTABLET, FILM COATED23
66715-9758-2Zantac 3601 in 1 CARTONTABLET, FILM COATED13
66715-9758-2Zantac 3602 in 1 BLISTER PACKTABLET, FILM COATED23
66715-9758-5Zantac 3601 in 1 CARTONTABLET, FILM COATED13
66715-9758-5Zantac 3605 in 1 BLISTER PACKTABLET, FILM COATED53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6458ZANTAC 360 (FAMOTIDINE TABLET, FILM-COATED) TABLET, FILM COATED ZANTAC 360, TRAVEL BASIX (FAMOTIDINE TABLET, FILM-COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC]3Current NDC, 2 package rows20241122_ea38535a-c9db-d03f-e053-2a95a90adf2d.zip
66715-9758ZANTAC 360 (FAMOTIDINE TABLET, FILM-COATED) TABLET, FILM COATED ZANTAC 360, TRAVEL BASIX (FAMOTIDINE TABLET, FILM-COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC]3Current NDC, Legacy NDC, 4 package rows20241122_ea38535a-c9db-d03f-e053-2a95a90adf2d.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-975866715-9758-5, 66715-9758-2
66715-645866715-6458-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
CARNAUBA WAXR12CBM0EIZIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FAMOTIDINE5QZO15J2Z8ACTIB
FERRIC OXIDE RED1K09F3G675IACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
CARNAUBA WAXR12CBM0EIZIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FAMOTIDINE5QZO15J2Z8ACTIB
FERRIC OXIDE RED1K09F3G675IACT

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 360, Travel BASIXFAMOTIDINE TABLET, FILM-COATEDLil' Drug Store Products, Incea38535a-c9db-d03f-e053-2a95a90adf2d2024-11-19WarningsExact identifier
ndc (package): 66715-6458-2
ndc (package): 66715-9758-2
ndc (package): 66715-9758-5
ndc (product): 66715-6458
ndc (product): 66715-9758
ndc11 (package): 66715975805
ndc11 (package): 66715645802
ndc11 (package): 66715975802
spl id: 274bc24b-823e-516d-e063-6394a90a2680
spl set id: ea38535a-c9db-d03f-e053-2a95a90adf2d

Reported adverse events (FAERS/openFDA)#

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