Ranitidine Tablets, USP

Manufacturer
AvPAK
Effective date
2019-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:23:57

Label at a glance#

ProductRanitidine
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 ...

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
◾  if you have kidney disease, except under the advice and supervision of a doctor

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

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

· safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

· store between 20°and 25°C (68°and 77°F)

· protect from excessive moisture and light

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 1-855-361-3993

CONSUMER INFORMATION

SPL UNCLASSIFIED SECTION

ranitidineimage.jpgranitidineimage.jpg

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150mg150mg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-721-152024-12-10C16284748780-11030e365-3fd3-111a-e063-dadaa90a10e2Ranitidine Tablets, USP
50268-721-152024-01-30C16284748780-11030e365-3fd3-111a-e063-dadaa90a10e2Ranitidine Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-721-11EA - Each50268-72136748395-662d-4f77-a6aa-95b0f14c484712019-11-12
50268-721-15EA - Each50268-72167112ddb-387c-4427-9250-8235830882d012019-10-07

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50268-72150268-721-11, 50268-721-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 1.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-03-09 01:35 UTC2022-03A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210243-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A210243-002RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-08-20782e0a99824c…

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
28eee19c-0467-3a0b-e063-6394a90aebaf891713fa-e572-371c-e053-2995a90ae88d2024-12-10WarningsExact identifier
spl set id: 891713fa-e572-371c-e053-2995a90ae88d