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
- Aphena Pharma Solutions - Tennessee, LLC
- Effective date
- 2016-06-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:46:30
Label at a glance#
ProductRanitidine
Active ingredientRanitidine Hydrochloride
Label structure12 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#
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 any 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)
- children under 12 years: ask a doctor
Other information
- do not use if printed foil under bottle cap is broken or torn
- 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, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and vanillin
Questions or Comments?
Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time)
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 150mg |
| 180 | 43353-952-80 |
| 1000 | 43353-952-71 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20160602DH
Principal Display Panel
Maximum Strength
Ranitidine Tablets USP, 150 mg 180 & 1000 ct bottle
Acid Reducer
Prevents & Relieves
Heartburn Associated with Acid Indigestion & Sour Stomach
Distributed by: Apotex Corp. Weston, Florida 33326, USA.
PRINCIPAL DISPLAY PANEL - 150mg
NDC 43353-952 - Ranitidine HCl 150mg - Rx Only
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| RANITIDINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7f54af34-be54-4c3c-894f-78df6452d747 | Product name | 3 | 20190703 |
| ccf8541e-b7dc-e6ba-06c9-15bf143a7850 | Product name | 5 | 20190611 |
| 05700d9e-ea6f-4aab-b0ed-1488f1d85d7b | Product name | 1 | 20180904 |
| 2f9d4e5c-e179-490e-8c43-f19e1e0ca228 | Product name | 1 | 20160720 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43353-952-71 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e9ab-f424-e053-dadaa90a57ce | Drug Facts |
| 43353-952-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e9ab-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43353-952-71 | Ranitidine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 1 | |
| 43353-952-80 | Ranitidine | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | 1 |
DailyMed Dashboard NDC Coverage#
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
- Vanillin
- Ferric Oxide Red
- Ferric Oxide Yellow
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43353-952 | 43353-952-80, 43353-952-71 |
| 60505-2880 |
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 |
| Vanillin | CHI530446X | IACT |
| Ferric Oxide Red | 1K09F3G675 | IACT |
| Ferric Oxide Yellow | EX438O2MRT | 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 |
|---|---|---|---|---|---|---|
| 1d958be7-19f4-4ad9-929c-409a037bda20 | 48d5c94c-4806-4b69-92d1-a0fc09ef9c96 | 2016-06-01 | Warnings | 1d958be7-19f4-4ad9-929c-409a037bda20 48d5c94c-4806-4b69-92d1-a0fc09ef9c96 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.