Maximum Strength Ranitidine

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2020-12-28
Label type
Human OTC Drug Label
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:59:18

Label at a glance#

ProductMaximum Strength Ranitidine
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure18 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) do not chew tablet 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#

SPL UNCLASSIFIED SECTION

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

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

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
  • kidney disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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)
    • do not chew tablet
  • 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, FD&C Blue No.1, hypromellose, magnesium stearate, microcrystalline cellulose, N & A MINT FL, sucralose, titanium dioxide and triacetin

Questions?

OTC - QUESTIONS SECTION

call 1-855-274-4122

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (65's Tablet Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-740-16
MAXIMUM STRENGTH
Ranitidine Tablets USP, 150 mg
COOL MINT TABLETS
ACID REDUCER
PREVENTS & RELIEVES HEARTBURN

associated with acid indigestion
and sour stomach
Sugar Free
RELEASES A COOLING SENSATION IN
MOUTH & THROAT
65 TABLETS (65 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (65's Tablet Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container (65's Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (65's Tablets Bottle Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


AUROHEALTH

NDC 58602-740-16

*Compare to the active

ingredient in Zantac 150® Cool Mint
MAXIMUM STRENGTH
Ranitidine
Tablets USP,
150 mg

COOL MINT TABLETS
ACID
REDUCER

Sugar Free
PREVENTS & RELIEVES
HEARTBURN
associated withacid
indigestion and sour stomach

RELEASES A COOLING SENSATION IN
MOUTH & THROAT
65 TABLETS (65 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (65's Tablets Bottle Carton)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Container Carton (65's Tablets Bottle Carton)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Blister Carton (24's (3 x 8) Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-740-72
*Compare to the active

Ingredient in Zantac 150® Cool Mint


MAXIMUM STRENGTH
Ranitidine
Tablets USP,
150 mg
COOL MINT TABLETS
ACID
REDUCER
Sugar Free
PREVENTS & RELIEVES
HEARTBURN
associated with acid
indigestion and sour stomach
RELEASES A COOLING SENSATION IN
MOUTH & THROAT
24 TABLETS (24 DOSES)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Blister Carton (24's (3 x 8) Tablets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Blister Carton (24's (3 x 8) Tablets)

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-74058602-740-16, 58602-740-20, 58602-740-79, 58602-740-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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…
2020-12-22 03:56 UTC2020-12A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207578-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2017-11-133f01610625f2…
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
0195f212-2504-4601-9e3c-da8497a52bbed0e4eb58-f3ea-4e51-b5fa-b5c39b472c5b2021-07-08WarningsExact identifier
spl set id: d0e4eb58-f3ea-4e51-b5fa-b5c39b472c5b

Reported adverse events (FAERS/openFDA)#

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