ACID REDUCER

Manufacturer
Dolgencorp, LLC | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2019-10-15
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:06:21

Label at a glance#

ProductACID REDUCER
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure16 sections

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

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

Storage and handling

TAMPER EVIDENT: Do Not Use If The Carton Or Printed Foil Under Cap Is Open or Torn store at 20° to 25°C (68° to 77°F) avoid excessive heat or humidity this product is sugar free USP Dissolution Test Pending

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride USP 167.414 mg)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION


  • 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

OTC - STOP USE SECTION

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION


  • 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

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: Do Not Use If The Carton Or Printed Foil Under Cap Is Open or Torn

  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat or humidity
  • this product is sugar free
  • USP Dissolution Test Pending

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin

Questions?

OTC - QUESTIONS SECTION

call 1-888-309-9030

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Consumer Information

SPL PATIENT PACKAGE INSERT SECTION

What you should know about
MAXIMUM STRENGTH
Ranitidine Tablets USP, 150 mg
ACID REDUCER

(Please read all of this information before taking MAXIMUM STRENGTH
Ranitidine Tablets 150 mg. Save this leaflet for future reference.)

What are MAXIMUM STRENGTH Ranitidine Tablets 150 mg?


  • MAXIMUM STRENGTH Ranitidine Tablets 150 mg contain 150 mg of ranitidine (as ranitidine hydrochloride USP, 167.414 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

Excellent Safety Record


  • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets 150 mg has been taken safely with many frequently prescribed medications.
  • MAXIMUM STRENGTH Ranitidine Tablets 150 mg are sugar free.

What symptoms do MAXIMUM STRENGTH Ranitidine Tablets 150 mg relieve and prevent?


  • MAXIMUM STRENGTH Ranitidine Tablets 150 mg relieve and prevent heartburn associated with acid indigestion and sour stomach.
  • Certain foods or beverages, and even lying down to sleep can cause heartburn associated with acid indigestion and sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.

Figure1Figure1
How should I take MAXIMUM STRENGTH Ranitidine Tablets 150 mg?


  • 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.
  • This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours).
  • MAXIMUM STRENGTH Ranitidine Tablets 150 mg should not be given to children under 12 years old unless directed by a doctor.
  • Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

How do MAXIMUM STRENGTH Ranitidine Tablets 150 mg work?

  • MAXIMUM STRENGTH Ranitidine Tablets 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

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

When should I see a doctor?

  • 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
  • If pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Questions? Call 1-888-309-9030

BOTTLES: Do not use if the carton or printed foil under cap is open or torn.

DISTRIBUTED BY:
DOLGENCORP, LLC
100 MISSION RIDGE,
GOODLETTSVILLE, TN 37072
MADE IN INDIA

Revised: 05/ 2019

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (24 Tablets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DG™ health

Maximum Strength Acid Reducer

Ranitidine Tablets 150 mg
Acid Reducer


PREVENTS & RELIEVES HEARTBURN
Associated with

Acid Indigestion

and Sour Stomach

 

8 Tablets (8 Doses)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (8 Tablets Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (8 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (24's Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


DG™ health

Compare to the
active Ingredient
of Zantac 1509®*


Maximum Strength
Acid
Reducer
Ranitidine Tablets 150 mg
Acid Reducer

PREVENTS & RELIEVES
HEARTBURN
Associated with
Acid Indigestion
and Sour Stomach

150 mg         8 Tablets (8 Doses)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (8 Tablets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (8 Tablets)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-09255910-092-79

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207578-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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2026-08-18 06:07:402026-07A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-135aa47cf7b7d7…
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2019-09-15 20:21 UTC2019-09A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fedc6d65-0481-42f9-b638-97e1f7c136a0d95fd14b-07a4-4bf7-89bd-dc9dfa50ec242021-07-08WarningsExact identifier
spl set id: d95fd14b-07a4-4bf7-89bd-dc9dfa50ec24

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.