Ranitidine
FDA Label NDC 55648-741

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wockhardt Limited for the product Ranitidine (NDC 55648-741). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Purpose

Acid reducer

Uses

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

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

Ask A Doctor Before Use If You Have

  • 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

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • 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

  • Blister: do not use if individual unit is open or torn 
    Bottle: 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 sugar free

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD and C yellow # 6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.

Otc - Questions

Questions or comments?Call 1-800-346-6854Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.Manufactured by:Wockhardt Limited,Mumbai, India.Distributed by:Wockhardt USA LLC.20 Waterview Blvd.Parsippany, NJ 07054 USA.Rev.151111

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