Ranitidine tablet, film coated

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 (1-800-222-1222).

Directions

  • adults and children 12 years and over:
    • to relievesymptoms, swallow 1 tablet with a glass of water
    • to preventsymptoms, swallow 1 tablet with a glass of water 30 to 60 minutes beforeeating 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 400, talc, titanium dioxide

Questions?

Call 1-888-287-1915

Ingredients and appearance - Product information

Ranitidine tablet, film coated- Ranitidine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49035-353
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ranitidine hydrochloride ( UNII: BK76465IHM)( Ranitidine - UNII: 884KT10YB7 ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Ferric oxide red ( UNII: 1K09F3G675)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color pink Size 8 mm
Shape ROUND Score 1
Imprint Code OR;606

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA201745 USA

Labeler - Wal-Mart Stores, Inc( 051957769)

Establishment

Name ID/FEI Business Operations
Wal-Mart Stores, Inc 051957769 MANUFACTURE( 49035-353)

Principal display panel

NDC 49035-353-30

equate

Compare to Zantac 75 ® Active Ingredient *

Regular Strength

Ranitidine Tablets, 75 mg

Acid Reducer

  • Prevents and Relieves Heartburn associated with acid indigestion and sour stomach

75 mg

30 TABLETS

Distributed by: Wal-Mart Stores, Inc.,

5114573 12/14