Ranitidine 75

RANITIDINE 75 — ranitidine hydrochloride tablet
REMEDYREPACK INC.

OTC — ACTIVE INGREDIENT

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

OTC — PURPOSE

Acid reducer

INDICATIONS & USAGE

  • 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

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

ask a health professional before use.

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

DOSAGE & ADMINISTRATION

  • 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

STORAGE AND HANDLING

  • do not use if printed foil under cap is broken or missing
  • store at 20° — 25°C (68° — 77°F)
  • avoid excessive heat or humidity
  • this product is sugar free

INACTIVE INGREDIENT

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.

OTC — QUESTIONS

1-800-719-9260

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Ranitidine 75

GENERIC: Ranitidine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-719-02

ACTIVE INGREDIENT(S):

  • RANITIDINE HYDROCHLORIDE 75mg in 1

COLOR: pink

SHAPE: HEXAGON (6 sided)

SCORE: No score

SIZE: 8 mm

IMPRINT: W75

PACKAGING: 30 in 1 BLISTER PACK

MM1
MM2
(click image for full-size original)
RANITIDINE 75
ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-719(NDC:0904-5818)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 75 mg
Product Characteristics
Color pink Score no score
Shape HEXAGON (6 sided) (TABLET) Size 8mm
Flavor Imprint Code W75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52125-719-02 30 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076760 09/26/2013
Labeler — REMEDYREPACK INC. (829572556)

Revised: 09/2013 REMEDYREPACK INC.

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