Ranitidine description, usages, side effects, indications, overdosage, supplying and lots more!

Ranitidine

Dr. Reddy's Laboratories Limited

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 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 eating or drinking 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

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

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.

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

  • 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

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

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

Ranitidine Tablets USP, 75 mg - Blister Carton Label

Package Label Principal Display Panel

Ranitidine Tablets USP, 75 mg - container label

Ranitidine Tablets USP, 75 mg - Container carton label

Ranitidine

Ranitidine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55111-131
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE RANITIDINE 75 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
FERROSOFERRIC OXIDE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
PINK 7 mm P75 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 30 in 1 BOTTLE
3 60 in 1 BOTTLE
4 80 in 1 BOTTLE
5 90 in 1 BOTTLE
6 120 in 1 BOTTLE
7 160 in 1 BOTTLE
8 10 in 1 BLISTER PACK
9 10 in 1 BLISTER PACK
10 10 in 1 BLISTER PACK
11 NDC:55111-131-81 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075294 2000-03-01


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Be sure to consult your doctor before taking any medication!
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