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
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
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
| Active ingredient (in each tablet) | Purpose |
| Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)...................................................................................................... | Acid reducer |
Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers
Do not use
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.
hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Call
1-888-285-9159 (English/Spanish)
M – F, 8:30 – 5 EST, or visit
www.zantacotc.com
Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.
Boehringer Ingelheim Consumer Health Care
Products
Division of Boehringer Ingelheim Pharmaceuticals,
Inc., Ridgefield, CT 06877
Copyright © 2015, Boehringer
Ingelheim Pharmaceuticals, Inc. All rights reserved.
Product
of Spain. Manufactured in Mexico.
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ranitidine hydrochloride | ACTIVE INGREDIENT | BK76465IHM | 4 | |
| ranitidine | ACTIVE MOIETY | 884KT10YB7 | 4 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 4 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 4 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0597-0121 | 0597-0121-06, 0597-0121-50, 0597-0121-08, 0597-0121-09, 0597-0121-24, 0597-0121-38, 0597-0121-64, 0597-0121-68, 0597-0121-80, 0597-0121-82, 0597-0121-94, 0597-0121-90, 0597-0121-85, 0597-0121-01, 0597-0121-78, 0597-0121-66, 0597-0121-11 |
Every source-derived ingredient row is available through these pages.
| 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 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| triacetin | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| triacetin | TRIACETIN | XHX3C3X673 | CONCENTRATE / ORAL | 250 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| triacetin | TRIACETIN | XHX3C3X673 | CAPSULE, EXTENDED RELEASE / ORAL | 467 mg | ||
| triacetin | TRIACETIN | XHX3C3X673 | TABLET, DELAYED RELEASE / ORAL | 23 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| triacetin | TRIACETIN | XHX3C3X673 | SYSTEM / TRANSDERMAL | 22.1 mg | ||
| triacetin | TRIACETIN | XHX3C3X673 | CAPSULE / ORAL | 13 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| 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 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 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 |
|---|---|---|---|---|---|---|
| b1cfa500-1895-4766-a712-34926848025e | 4da36a98-7363-4a8a-9bfe-5dfa7d2e1268 | 2021-05-01 | Warnings | 4da36a98-7363-4a8a-9bfe-5dfa7d2e1268 |
Adverse event summaries are temporarily unavailable. Other product information remains available.