Ranitidine Tablets

Manufacturer
Granules India Ltd
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-10-10 01:03:11

Label at a glance#

ProductRanitidine cool mint
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure15 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) ◾ do not chew tablet (for cool mint tablets only) ◾ children under 12 years: ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 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

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 taking a prescription drug. Acid reducers may interact with 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

PREGNANCY/BREASTFEEDING

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.

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 (for cool mint tablets only)

◾ children under 12 years: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

◾ do not use if individual blister unit is open or torn.

◾ do not use if printed foil under bottle cap is open or torn

◾ store at 20 0-25 0​C (68 0​-77 0​F)

◾ avoid excessive heat or humidity

◾ this product is sodium and sugar free

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

For 150 mg:croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,talcum, titanium dioxide

For 150 mg cool mint:acacia, croscarmellose sodium, FD&C Blue No. 1,magnesium stearate, menthol, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, talcum,
titanium dioxide

Questions or comments?

SPL UNCLASSIFIED SECTION

•Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM EST.

This product is not manufactured or distributed by Boehringer Ingelheim ® consumer health care products, distributor of Zantac 150mg and 150mg Cool Mint

Read the directions and warnings before use.

SPL UNCLASSIFIED SECTION

Keep the carton. It contains important information including tips for managing heartburn.

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 andfried 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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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62207-774-3262207-774-32

62207-774-3662207-774-36

62207-774-41-carton62207-774-41-carton

62207-774-47-carton62207-774-47-carton

62207-774-58-carton62207-774-58-carton

ranitidine-150mg-label1ranitidine-150mg-label1

ranitidine-150mg-label2ranitidine-150mg-label2

ranitidine-label3ranitidine-label3

ranitidine-label4ranitidine-label4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)50362207773367(17)000000(10)XXXXXXXGTIN-14: 50362207773367
GTIN storage (14 digits): 50362207773367
62207-773-36-carton.jpg
BarcodeCode 128(01)50362207774364(17)000000(10)XXXXXXXGTIN-14: 50362207774364
GTIN storage (14 digits): 50362207774364
62207-774-36.jpg
Data codeCode 128(00)18903832000000000462207-773-36-carton.jpg, 62207-774-36.jpg
Data codeData MatrixP0407064ranitidine-label4-jpg.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-12-02full-release2026-06-01 01:19:09

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210243-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20
A210243-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2084e616aacf4f…
2026-09-14 22:38:342026-08A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2084e616aacf4f…
2026-08-18 06:07:402026-07A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20caaa826d4ba7…
2026-08-18 06:07:402026-07A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-2074a2ff9319b5…

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
44f2b222-ae43-eef4-e063-6394a90ab2b6aab81d9f-397d-49fb-8083-77a1872cc71f2025-12-02WarningsExact identifier
spl set id: aab81d9f-397d-49fb-8083-77a1872cc71f

Reported adverse events (FAERS/openFDA)#

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