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
Acid Reducer
- Manufacturer
- Strides Pharma Inc | Strides Pharma Science Limited
- Effective date
- 2019-09-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:59:11
Label at a glance#
ProductAcid Reducer
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) children under 12 years: ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 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
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
- kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT 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
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide
QUESTIONS?
Call 1-877-244-9825
Tips for managing heartburn
- Do not lie flat or bend over soon after eating
- Do not eat late at night, or just before bedtime
- Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
- Eat slowly and do not eat big meals
- If you are overweight, lose weight
- If you smoke, quit smoking
- Raise the head of your bed
- Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.
Manufactured by:
Strides Pharma Science Ltd.
Puducherry - 605 014, India.
PON/DRUGS/16 13 4193
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Revised: 09/2019
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ranitidine Tablets, USP 75 mg
NDC 59556-945-04
30's count
Products#
Every source-derived product name is available through these pages.
- Acid Reducer
- ranitidine hydrochloride
- RANITIDINE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- HYPROMELLOSES
- FERRIC OXIDE RED
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL 400
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59556-945 | 59556-945-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| RANITIDINE HYDROCHLORIDE | BK76465IHM | ACTIM |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|---|
| A201745-001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 |
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 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A201745-001 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | 2012-02-29 | 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 |
|---|---|---|---|---|---|---|
| 534b48c0-1967-4bfa-b5e6-e3afd0aefce4 | a33bd585-e218-4ff0-9d8d-7c2fe858ddf2 | 2022-10-27 | Warnings | a33bd585-e218-4ff0-9d8d-7c2fe858ddf2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.