Ranitidine

Manufacturer
Sam's West Inc
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:22:30

Label at a glance#

ProductRanitidine
Active ingredientRanitidine Hydrochloride
Label structure14 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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use(s)

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

SPL UNCLASSIFIED SECTION

• taking a prescription drug. Acid reducers may interactwith certain prescription drugs.

Stop use and ask 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 right away (1-800-222-1222).

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

SPL UNCLASSIFIED SECTION

  • do not use if printed foil under bottle cap is open or torn
  • store at 20°-25°C (68°-77°F)
  • avoid excessive heat or humidity
  • protect from light
  • this product is sodium and sugar free

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

Revised: 0419

Consumer Information

SPL UNCLASSIFIED SECTION

What you should know about

MAXIMUM STRENGTH

Ranitidine Tablets USP, 150 mg

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

What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 150 mg of ranitidine (as ranitidine hydrochloride USP, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

Excellent Safety Record

  • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 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 USP, 150 mg has been taken safely with many frequently prescribed medications.
  • MAXIMUM STRENGTH Ranitidne Tablets USP, 150 mg are sodium and sugar free.

What symptoms does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 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 to 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.

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How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 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 (up to 2 tablets in 24 hours).

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 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 does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets USP, 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

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

When should I see 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.
  • heartbrun 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 reducersmay 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 (1-800-222-1222).

Questions? Call 1-888-375-3784

BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn.

BLISTERS: Do not use if the individual blister unit is open or torn.

Revised: 0419

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION. IMPORTANT:

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

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label:

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength
Ranitidine Tablets USP,150 mg
ACID REDUCER


PREVENTS & RELIEVES
heartburn associated with acid indigestion
and sour stomach

190 Tablets(190 doses)

CartonCarton


Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength
Ranitidine Tablets USP,150 mg
ACID REDUCER


PREVENTS & RELIEVES
heartburn associated with acid indigestion
and sour stomach

95 Tablets(95 doses)

BottleBottle


FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-985-192025-07-24C16284748780-12cef2736-a75f-d83d-e063-dadaa90ab31fDrug Facts
68196-985-192025-01-30C16284748780-12cef2736-a75f-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-985RANITIDINE TABLET, COATED [SAM'S WEST INC]4Legacy NDC20231103_36bd757d-f31a-b1fd-2372-fee11a264625.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-404-34EA - Each55111-40477f8c9e5-f9d2-4d80-88c6-7059a252ae0612015-09-10

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
68196-98568196-985-19
55111-404

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
A078192-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31

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.

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
2026-09-14 22:38:342026-08A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3184e616aacf4f…
2026-08-18 06:07:402026-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1a0e038a-486f-24ec-5e43-a6821f4b48d036bd757d-f31a-b1fd-2372-fee11a2646252025-07-24WarningsExact identifier
spl set id: 36bd757d-f31a-b1fd-2372-fee11a264625
RanitidineRANITIDINEDr. Reddy's Laboratories Limited00df8a42-296f-80dd-98af-ee8b30eb38cc2025-05-23WarningsExact identifier
ndc (product): 55111-404

Reported adverse events (FAERS/openFDA)#

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