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
Ranitidine
- Manufacturer
- H-E-B | Apotex Inc. | Apotex Inc
- Effective date
- 2018-01-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:04:17
Label at a glance#
ProductRanitidine
Active ingredientRanitidine Hydrochloride
Label structure11 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#
Label contents#
Full prescribing information#
SPL PRODUCT DATA ELEMENTS SECTION
SPL UNCLASSIFIED SECTION
Active ingredient (in each tablet)
Ranitidine 150 mg (as ranitidine hydrochloride, USP 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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 seal under bottle cap is broken or missing (bottles)
- do not use if individual blister unit is open or torn (blisters)
- store at 20°C to 25°C (68°F to 77°F)
- avoid excessive heat or humidity
- this product is sodium and sugar free
Inactive ingredients
carnauba wax, colloidal silicon dioxide, cool vanilla mint flavor, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide
Questions or Comments?
Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time)
PRINCIPAL DISPLAY PANEL
Cool Mint Tablets
Maximum Strength
Acid Reducer
Ranitidine Tablets USP, 150 mg - Bottle Label - 24 Tablets
Prevents & Relieves Heartburn
Associated with Acid Indigestion & Sour Stomach
Releases a Cooling Sensation in Mouth & Throat
Sugar Free
Distributed by: HEB
PRINCIPAL DISPLAY PANEL
Cool Mint Tablets
Maximum Strength
Acid Reducer
Ranitidine Tablets USP, 150 mg - Carton Label - 24 Tablets
Prevents & Relieves Heartburn
Associated with Acid Indigestion & Sour Stomach
Releases a Cooling Sensation in Mouth & Throat
Sugar Free
Distributed by: HEB
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37808-303-02 | 2022-06-14 | C162847 | 48780-1 | c7ccaba7-27c6-fd44-e053-dadaa90aa01b | Drug Facts |
| 37808-303-02 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-27c6-fd44-e053-dadaa90aa01b | Drug Facts |
Products#
Every source-derived product name is available through these pages.
- Ranitidine
- Ranitidine Hydrochloride
- Carnauba Wax
- Silicon Dioxide
- Hypromelloses
- Magnesium Stearate
- Cellulose, Microcrystalline
- Polydextrose
- Titanium Dioxide
- Fd&C Blue No. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37808-303 | 37808-303-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Ranitidine Hydrochloride | BK76465IHM | ACTIM |
| Carnauba Wax | R12CBM0EIZ | IACT |
| Silicon Dioxide | ETJ7Z6XBU4 | IACT |
| Hypromelloses | 3NXW29V3WO | IACT |
| Magnesium Stearate | 70097M6I30 | IACT |
| Cellulose, Microcrystalline | OP1R32D61U | IACT |
| Polydextrose | VH2XOU12IE | IACT |
| Titanium Dioxide | 15FIX9V2JP | IACT |
| Fd&C Blue No. 1 | H3R47K3TBD | 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 |
|---|---|---|---|---|---|---|---|
| A200172-001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 |
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 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A200172-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2012-05-31 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 37439e58-1128-8cd8-613a-aa3e4bb0f413 | d1f39d44-9fed-e72c-9011-d153bbfce894 | 2022-06-14 | Warnings | d1f39d44-9fed-e72c-9011-d153bbfce894 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.