Ranitidine 75

Manufacturer
Target Brands Inc
Effective date
2014-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:37:18

Label at a glance#

ProductRanitidine 75
Active ingredientranitidine hydrochloride
Label structure11 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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 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

  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.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)
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Question Section

OTC - QUESTIONS SECTION

Questions? call 1-888-375-3784

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

Ranitidine Tablets USP, 75 mg - container label

containercontainer

Ranitidine Tablets USP, 75 mg - Container carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ranitidine Tablets USP, 75 mg - Container carton label

containercartoncontainercarton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-131-60EA - Each55111-1310f78e0cf-e93c-462a-ac98-19f5df90981412018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ranitidine hydrochlorideACTIVE INGREDIENTBK76465IHM1
ranitidineACTIVE MOIETY884KT10YB71
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F3571
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
magnesium stearateINACTIVE INGREDIENT70097M6I301
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1A1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1

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
11673-13111673-131-30, 11673-131-80
55111-131

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
ferrosoferric oxideFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form

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
A075294-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28

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 22:38:342026-08A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28f41ea6bd6efb…

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
RanitidineRANITIDINEDr. Reddy's Laboratories Limited12a38e29-130c-6d41-1753-acccb0b41efe2025-05-23WarningsExact identifier
ndc (product): 55111-131
ab3054ab-256f-2c16-708c-b5a0aed451d341d04909-af83-2afe-d442-e635dcd1ea162019-12-12WarningsExact identifier
spl set id: 41d04909-af83-2afe-d442-e635dcd1ea16

Reported adverse events (FAERS/openFDA)#

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