REGULAR STRENGTH Ranitidine Tablets USP, 75 mg

Manufacturer
Gericare Pharmaceuticals | Strides Pharma Global Pte. Ltd. | Vivimed Life Sciences Private Limited
Effective date
2020-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:32:25

Label at a glance#

ProductRanitidine
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure15 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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

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

  • 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 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 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

OTHER SAFETY INFORMATION

  • store at 20º to 25ºC (68º to 77ºF)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, ferric oxide red, ferric oxide yellow, glyceryl monostearate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulphate, talc, and titanium dioxide

Questions

OTC - QUESTIONS SECTION

call 1-800-540-3765

Manufactured in INDIA for:

Gericare Pharmaceuticals,

1650 63 Street, Brooklyn, NY 11204

M.L. No.: TN00002326

Rev. 05/2019              

Consumer Information Leaflet

SPL UNCLASSIFIED SECTION

What you should know about

REGULAR STRENGTH

Ranitidine Tablets USP, 75 mg/ Acid Reducer

(Please read all of this information before taking Ranitidine Tablets USP, 75 mg. Save this leaflet for future reference.)

What are Ranitidine Tablets USP, 75 mg?

  • Ranitidine Tablets USP, 75 mg contains 75 mg of ranitidine (as ranitidine hydrochloride USP, 84 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

Excellent Safety Record

  • Ranitidine Tablets USP, 75 mg has been used safely and effectively for years as on over-the-counter.
  • Ranitidine Tablets USP, 75 mg are sodium and sugar free.

What symptoms does Ranitidine Tablets USP, 75 mg relieve and prevent?

  • Ranitidine Tablets USP, 75 mg relieves and prevents 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 for 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.
figure-1
figure-1

How should I take Ranitidine Tablets USP, 75 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 (do not take more than 2 tablets in 24 hours).
  • Do not chew tablet.
  • Ranitidine Tablets USP, 75 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 Ranitidine Tablets USP, 75 mg work?

  • Ranitidine Tablets USP, 75 mg reduces the production of stomach acid. This is what makes Ranitidine Tablets USP, 75 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

Additional 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
figure-2
figure-2

When should I see a doctor?

  • 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
  • Ask a doctor before use if you have
    • 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 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.

Questions? call 1-800-540-3765

Manufactured by:

Vivimed Life Sciences Private Limited,

Plot No. 101, 102, 107 & 108,

SIDCO Pharmaceutical Complex, Alathur,

Kanchipuram – 603 110, Tamilnadu, India.

Distributed by:

Gericare Pharmaceuticals,

1650 63 Street, Brooklyn, NY 11204

Rev. 05/2020              

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57896-712-01

REGULAR STRENGTH

Ranitidine Tablets, USP

75 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

10000 film coated tablets

Gericare

10000 bag pack
10000 bag pack

NDC 57896-712-03

REGULAR STRENGTH

Ranitidine Tablets, USP

75 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

30 film coated tablets

Gericare

30's pack
30's pack

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-71257896-712-01, 57896-712-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

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#

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Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209160-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05

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
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2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-055bbf6a4d5a75…
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2024-10-29 15:01 UTC2024-10A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-051e350fbaab3a…
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2024-02-18 07:12 UTC2024-02A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-053bdfa0b2c4d7…
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2022-10-28 04:53 UTC2022-10A209160-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2018-03-05f41ea6bd6efb…

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6723a94-95aa-7996-e053-2995a90a3d35c16a8831-9801-4f3e-8bba-e2c6f045ef9e2020-12-14WarningsExact identifier
spl set id: c16a8831-9801-4f3e-8bba-e2c6f045ef9e

Reported adverse events (FAERS/openFDA)#

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