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

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Ranitidine Hydrochloride

Dr. Reddy's Laboratories Limited

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)

Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 mg)

Purpose

Acid reducer

Use(s)

  • 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 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

Ranitidine Hydrochloride Other 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
  • protect from light
  • this product is sugar free

Inactive ingredients

FD&C red 40, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide

Questions

call 1-888-375-3784

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR  PROTECTION.

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

CARTON LABELING - PRINCIPAL DISPLAY PANEL

Carton :

Ranitidine Hydrochloride

Ranitidine Hydrochloride

Ranitidine Hydrochloride TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55111-404
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE RANITIDINE 168 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
HYPROMELLOSE 2910 (6 MPA.S)
FERROSOFERRIC OXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
PINK 9 mm R150 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 50 in 1 BOTTLE
3 65 in 1 BOTTLE
4 95 in 1 BOTTLE
5 8 in 1 BLISTER PACK
6 8 in 1 BLISTER PACK
7 8 in 1 BLISTER PACK
8 NDC:55111-404-38 4 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078192 2009-12-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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