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
Zantac 150
- Manufacturer
- Chattem, Inc.
- Effective date
- 2018-01-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:46:57
Label at a glance#
ProductZantac 150 Maximum Strength Cool Mint
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure10 sections
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#
Websitewww.zantacotc.com
www.zantacotc.com
www.zantacotc.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Zantac 150 Cool Mint Tablets
Drug Facts
Active ingredient (in each tablet)
Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)
Purpose
Acid reducer
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
Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers
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
■ if you have kidney disease, except under the advice and supervision of a doctor
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
Stop use and ask a doctor if
■ 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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
■ 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
■ 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
FD&C Blue No. 1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions?
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
Cool Mint TABLETS
Maximum Strength
Zantac
150
40 Tablets
Products#
Every source-derived product name is available through these pages.
- Zantac 150 Maximum Strength Cool Mint
- Ranitidine Hydrochloride
- RANITIDINE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYSORBATE 80
- SUCRALOSE
- FD&C BLUE NO. 1
- HYPROMELLOSE, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41167-0320 | 41167-0320-1, 41167-0320-2, 41167-0320-0, 41167-0320-6, 41167-0320-3, 41167-0320-4, 41167-0320-7, 41167-0320-5 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| RANITIDINE HYDROCHLORIDE | BK76465IHM | ACTIM |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021698-001 | ZANTAC 150 | EQ 150MG BASE | TABLET / ORAL | RLD, RS | 2004-08-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021698-002 | ZANTAC 150 | EQ 150MG BASE | TABLET / ORAL | RLD | 2007-03-13 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a4caffbb-1e0f-4fb1-b297-3a548f7868fd | 46da3875-7a43-4a13-ae0b-3243fe2c2f56 | 2018-01-04 | Warnings | 46da3875-7a43-4a13-ae0b-3243fe2c2f56 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.