Zantac 150

Manufacturer: Chattem, Inc.
Effective date: 2018-04-03
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 23:46:58

Label at a glance#

ProductZantac 150 Maximum Strength

Active ingredientRANITIDINE HYDROCHLORIDE

Label structure10 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) children under 12 years: ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-633-1610

Websitewww.zantacotc.com

www.zantacotc.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Zantac 150®

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride 168 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 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
if you have kidney disease, except under the advice and supervision of a doctor

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,

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 printed foil under bottle cap is open or torn
store at 20-25°C (68-77°F)
avoid excessive heat or humidity
this product is sodium and sugar free

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
Zantac 150
Ranitidine 150 mg/ Acid reducer
90 TABLETS
(90 DOSES)

PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH Zantac 150 Ranitidine 150 mg/ Acid reducer 90 TABLETS (90 DOSES)

Products#

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

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

Zantac 150 Maximum Strength
Ranitidine Hydrochloride
RANITIDINE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE RED
TITANIUM DIOXIDE
TRIACETIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-0310	41167-0310-1, 41167-0310-2, 41167-0310-3, 41167-0310-7, 41167-0310-4, 41167-0310-5, 41167-0310-8, 41167-0310-9, 41167-0310-6, 41167-0310-0

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

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021698-001	ZANTAC 150	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		RLD	2004-08-31
N021698-002	ZANTAC 150	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		RLD	2007-03-13

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 · 88 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	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021698-001	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2004-08-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021698-002	ZANTAC 150	EQ 150MG BASE	TABLET / ORAL	RLD	2007-03-13	`4b0b4de00fa7…`

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
7dfde990-4bbd-4f3b-8fbf-1cdf164223cf			78380bf5-7ab6-42da-a02c-24644db778ff	2018-04-03	Warnings	Exact identifier spl set id: 78380bf5-7ab6-42da-a02c-24644db778ff

Reported adverse events (FAERS/openFDA)#

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