Zantac

Manufacturer: Central Texas Community Health Centers | Travis County Healthcare District
Effective date: 2018-04-26
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:55:16

Label at a glance#

ProductZantac

Active ingredientRANITIDINE HYDROCHLORIDE

Label structure14 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 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) do not chew tablet 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#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

*Active ingredient (in each tablet)*	*Purpose*
Ranitidine 75 mg (as ranitidine hydrochloride 84 mg) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	Acid reducer

Uses

OTC - PURPOSE 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 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 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

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, 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.

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)
- do not chew tablet
children under 12 years: ask a doctor

Other information

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

do not use if printed foil under bottle cap is open or torn (bottles)
do not use if individual blister unit is open or torn (blisters)
do not use if individual foil packet is open or torn (pouch)
store at 20-25ºC (68-77ºF)
avoid excessive heat or humidity
this product is sodium and sugar free

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, microcrystalline cellulose, iron oxide, titanium dioxide, triacetin

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products
Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877
© 2016, BI Pharmaceuticals, Inc. All rights reserved.
Product of Spain. Manufactured in Mexico.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 76413-317

NDC: 76413-317-30 10 TABLET, COATED in a BLISTER PACK / 3 in a CARTON

Zantac

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
312773	ranitidine 75 MG Oral Tablet	PSN	4
827183	Zantac 75 MG Oral Tablet	PSN	4
827183	ranitidine 75 MG Oral Tablet [Zantac]	SBD	4
312773	ranitidine 75 MG Oral Tablet	SCD	4
312773	ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral Tablet	SY	4
827183	Zantac 75 75 MG Oral Tablet	SY	4
827183	Zantac 75 MG (as ranitidine hydrochloride 84 MG) Oral Tablet	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
RANITIDINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7f54af34-be54-4c3c-894f-78df6452d747	Product name	3	20190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850	Product name	5	20190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7b	Product name	1	20180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228	Product name	1	20160720

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76413-317-30	2020-01-31	C162847	48780-1	9d75b9d0-7dfb-f424-e053-dadaa90a57ce	Zantac 75 ® Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76413-317-30	Zantac	3 in 1 CARTON	TABLET, COATED	3		4
76413-317-30	Zantac	10 in 1 BLISTER PACK	TABLET, COATED	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76413-317	ZANTAC (RANITIDINE) TABLET, COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]	4	Legacy NDC, 2 package rows	20180427_2e846995-48b9-4062-b6f7-46884d411039.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0122-13	EA - Each	0597-0122	5a13a602-c54e-42c4-9cef-24838673b0bf	1	2019-01-24
0597-0122-27	EA - Each	0597-0122	afb7291f-7243-4c18-bdee-e0879aa0c616	1	2012-07-24
0597-0122-37	EA - Each	0597-0122	ee19f11b-ad30-42d0-891e-1107a171b390	1	2012-07-24
0597-0122-54	EA - Each	0597-0122	ed679226-297f-44f2-bdb7-4858939d94af	1	2012-07-24
0597-0122-81	EA - Each	0597-0122	3cff1c2d-45e2-42a7-9fba-d96088f38dcb	1	2012-07-24

Products#

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

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

Zantac
ranitidine
RANITIDINE HYDROCHLORIDE
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
ferric oxide red
titanium dioxide
triacetin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76413-317	76413-317-30
0597-0122

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
RANITIDINE HYDROCHLORIDE	BK76465IHM	ACTIM
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
magnesium stearate	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
ferric oxide red	1K09F3G675	IACT
titanium dioxide	15FIX9V2JP	IACT
triacetin	XHX3C3X673	IACT

Source Document#

Source XML · Source PDF

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 · 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 · 43 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	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…`
2022-10-28 04:53 UTC	2022-10	N020520-001	ZANTAC 75	EQ 75MG BASE	TABLET / ORAL	RLD	1995-12-19	`f41ea6bd6efb…`

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
5a3058ab-e988-4010-99df-ee481cdd862c			2e846995-48b9-4062-b6f7-46884d411039	2018-04-26	Warnings	Exact identifier spl id: 5a3058ab-e988-4010-99df-ee481cdd862c spl set id: 2e846995-48b9-4062-b6f7-46884d411039

Reported adverse events (FAERS/openFDA)#

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