MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg

Manufacturer
Vivimed Labs Limited | Strides Vivimed Pte. Ltd. | Vivimed Life Sciences Private Limited
Effective date
2019-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:34:39

Label at a glance#

ProductRanitidine 150 mg
Active ingredientRANITIDINE HYDROCHLORIDE
Label structure16 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#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

 Active ingredient (in each tablet) Purpose
Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)............................................................................................................. Acid reducer

Uses

OTC - PURPOSE 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 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.

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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call Vivimed Labs USA at 732-398-0008

Consumer Information Leaflet

SPL UNCLASSIFIED SECTION

What you should know about

MAXIMUM STRENGTH
Ranitidine Tablets USP, 150 mg/ Acid Reducer

(Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference.)

What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contain 150 mg of ranitidine (as ranitidine hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide.

Excellent Safety Record

  • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg has been taken safely with many frequently prescribed medications.
  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg are sodium and sugar free.

What symptoms does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent 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.
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How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 150 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).
  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 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 MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work?

  • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduce the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets USP, 150 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
  • 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
    • if you have kidney disease, except under the advice and supervision of a doctor

When should I see a doctor?

  • 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.

Questions?

call Vivimed Labs USA at 732-398-0008

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.

Manufactured by:

Vivimed Life Sciences Private Limited,
Plot No. 101, 102, 107 & 108,
SIDCO Pharmaceutical Complex,
Alathur, Kanchipuram Dist – 603 110, Tamilnadu, India.

Distributed by:

Vivimed Labs USA,
1100 Cornwall Road,
Suite 160, Monmouth Junction,
NJ 08852, USA.

Rev. 12/2016
XX000000-01

Ranitidine Tablets USP, 150 mg - 30's count container carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62980-512-01

MAXIMUM STRENGTH
Ranitidine Tablets, USP

150 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

30 film coated tablets

Vivimed

Read the directions, consumer information leaflet and warnings before use. Keep the carton.
It contains important information.

image1image1

Ranitidine Tablets USP, 150 mg - 500's count container carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62980-512-02

MAXIMUM STRENGTH

Ranitidine Tablets, USP

150 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

500 film coated tablets

Vivimed

Read the directions, consumer information leaflet and warnings before use. Keep the carton.
It contains important information.

image2image2

Ranitidine Tablets USP, 150 mg - 4 x 7's blister carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62980-512-04

MAXIMUM STRENGTH
Ranitidine Tablets, USP

150 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

28 film-coated tablets (4 x 7’s Blister pack)

Vivimed

Read the directions, consumer information leaflet and warnings before use.
Keep the carton. It contains important information.

image3image3

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
62980-51262980-512-01, 62980-512-02, 62980-512-03, 62980-512-04

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
A209161-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2018-02-22

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e5b5da9-18b6-45e5-9fe0-efeb232029a35cc82f9c-2d60-4304-84fb-59b1438e4f042019-11-26WarningsExact identifier
spl set id: 5cc82f9c-2d60-4304-84fb-59b1438e4f04

Reported adverse events (FAERS/openFDA)#

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