Zantac 75

Manufacturer: JC World Bell Wholesale Co., Inc.
Effective date: 2021-10-19
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 22:31:34

Label at a glance#

ProductZantac 75

Active ingredientRANITIDINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

relieves heartburn associated with acid indigestion and sour stomach relieves heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Dosage and administration

adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor

Contacts and useful links#

PhoneLabel contact1-888-285-9159

Websitewww.zantacotc.com

www.zantacotc.com

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach
relieves heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to ranitidine 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 hertburn 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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over:
to relieve symptoms, swallow 1 tablet with a glass of water
to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
can be used up to twice daily (do not take more than 2 tablets in 24 hours)
children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

do not use if individual foil pouch is open or torn
avoid excessive heat or humidity
store at 20 ⁰-25 ⁰C (68 ⁰-77 ⁰F)
this product is sodium and sugar free

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide,titanium dioxide, triacetin.

Inactive ingredients

OTC - QUESTIONS SECTION

call 1-888-285-9159 (English/Spanish)M-F, 8:30-5 EST, or visit www.zantacotc.com for Tips for Managing Heartburn

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Zantac 75
RANITIDINE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
TITANIUM DIOXIDE
TRIACETIN
RANITIDINE HYDROCHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50269-222	50269-222-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
RANITIDINE HYDROCHLORIDE	BK76465IHM	ACTIM

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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020520-001	ZANTAC 75	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL		RLD	1995-12-19

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`3a93d1ddd44b…`

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
ceb957ce-9d0f-7d32-e053-2a95a90ad9b9			1f79c236-966d-4398-aa4b-88d67967f78b	2021-10-19	Warnings	Exact identifier spl id: ceb957ce-9d0f-7d32-e053-2a95a90ad9b9 spl set id: 1f79c236-966d-4398-aa4b-88d67967f78b

Reported adverse events (FAERS/openFDA)#

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

Zantac 75

Label at a glance#

Indications and uses

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

​Purpose

​Uses

​Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

​Directions

​Other information

​Inactive ingredients

Inactive ingredients

​Package Labeling:

Products#

NDC Codes#

Ingredients#

Source Document#

Orange Book application contexts#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Package Labeling: