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

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Acid Reducer

Major Pharmaceuticals
Ranbaxy Pharmaceuticals Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT (IN EACH TABLET)

Ranitidine 150 mg (as ranitidine hydrochloride, USP 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 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
  • 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

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 (1-800-222-1222).

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

  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER 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

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

QUESTIONS?

call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-6350-51

MAXIMUM STRENGTH

RANITIDINE 150

Ranitidine Tablets, USP 150 mg

Acid Reducer

Prevents and Relieves Heartburn associated with Acid Indigestion and Sour Stomach

COMPARE TO the active ingredient of ZANTAC 150®*

50 Tablets

Distributed By: MAJOR® PHARMACEUTICALS

5104472/0813

Acid Reducer

Ranitidine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-6350
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE RANITIDINE 150 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
ferric oxide red
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
pink 12 mm 9R OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 50 in 1 BOTTLE
3 NDC:0904-6350-51 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200536 2013-10-01


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