acid reducer

Manufacturer
CVS Pharmacy
Effective date
2018-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:55:37

Label at a glance#

Productacid reducer
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure14 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#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 75 mg (as ranitidine hydrochloride 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

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 (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)
  • do not chew tablet
  • children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • 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
  • this product is sodium and sugar free

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, natural and artificial mint flavor, sucralose, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Consumer information

OTHER SAFETY INFORMATION

What you should know about COOL MINT Ranitidine Tablets, 75 mg Acid Reducer

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

What are Cool Mint Ranitidine Tablets, 75 mg?

  • Cool Mint Ranitidine Tablets, 75 mg contain 75 mg of ranitidine (as ranitidine hydrochloride, 84 mg), a medicine that doctors have prescribed more than 200 million times worldwide.
  • When swallowed, Cool Mint Ranitidine Tablets, 75 mg release a cooling sensation in the mouth and throat.
cool mint ranitidine
cool mint ranitidine

Excellent Safety Record

  • The ingredient in Cool Mint Ranitidine Tablets, 75 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in Cool Mint Ranitidine Tablets, 75 mg has been taken safely with many frequently prescribed medications.
  • Cool Mint Ranitidine Tablets, 75 mg are sodium and sugar free.

What symptoms do Cool Mint Ranitidine Tablets, 75 mg relieve and prevent?

  • Cool Mint Ranitidine Tablets, 75 mg relieve and prevent heartburn associated with acid indigestion and sour stomach. Eating or drinking 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.

How should I take Cool Mint Ranitidine Tablets, 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.
  • Cool Mint Ranitidine Tablets, 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 do Cool Mint Ranitidine Tablets, 75 mg work?

  • Cool Mint Ranitidine Tablets, 75 mg reduce the production of stomach acid. This is what makes Cool Mint Ranitidine Tablets, 75 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

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
  • 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 healthcare 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 or comments?

1-800-719-9260

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.

Distributed by Perrigo® Allegan MI 49010

:5U60000J1

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE SIZE 150 TABLETS

Compare to the active ingredient in Zantac 75® Cool Mint

Regular Strength

Acid Reducer

RANITIDINE TABLETS USP, 75 mg

Acid Reducer

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion & sour stomach

Releases a Cooling Sensation in Mouth & Throat

Actual Size

Sugar Free

Cool Mint Tablets

150 TABLETS (150 Doses)

Package Contains One Bottle

acid-reducer-image
acid-reducer-image

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-30769842-307-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
A076195-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30

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
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2026-08-18 06:07:402026-07A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-303f01610625f2…
2019-09-15 20:21 UTC2019-09A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076195-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2002-08-30f41ea6bd6efb…

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
52759449-cc3f-42a0-8fcb-662ecd5dc74b77055179-82ea-4f44-993d-d01436b041742020-10-26WarningsExact identifier
spl set id: 77055179-82ea-4f44-993d-d01436b04174

Reported adverse events (FAERS/openFDA)#

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