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
- Navajo Manufacturing Company Inc.
- Effective date
- 2019-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:55:22
Label at a glance#
ProductZantac 150
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure8 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) • children under 12 years: ask a doctor
Contacts and useful links#
Websitewww.zantacotc.com
www.zantacotc.com
www.zantacotc.comLabel contents#
Full prescribing information#
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, necks 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)
• children under 12 years: ask a doctor
Other information
• do not use if individual foil pouch 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
hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions?
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:
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0597-0121-24 | EA - Each | 0597-0121 | f5302b60-3cb0-4798-945e-392de372d736 | 1 | 2012-07-24 |
| 0597-0121-50 | EA - Each | 0597-0121 | 52fe690d-3c38-4b1f-8236-f13a7248401d | 1 | 2012-07-24 |
| 0597-0121-68 | EA - Each | 0597-0121 | 8b633da4-67ec-4fdf-9e51-981627caa051 | 1 | 2012-07-24 |
| 0597-0121-90 | EA - Each | 0597-0121 | bdb0cd21-0472-4295-ae3f-73af5ddcb287 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Zantac 150
- RANITIDINE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- TITANIUM DIOXIDE
- TRIACETIN
- RANITIDINE HYDROCHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67751-151 | 67751-151-01 |
| 0597-0121 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| RANITIDINE HYDROCHLORIDE | BK76465IHM | ACTIM |
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 |
|---|---|---|---|---|---|---|
| e4e3fd9b-1035-2015-e053-2995a90a45b7 | 4e7e07a5-4fc6-4d31-9f75-3920e823da17 | 2022-07-28 | Warnings | 4e7e07a5-4fc6-4d31-9f75-3920e823da17 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.