Home – Zantac 75

Zantac 75

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)	Purpose
Ranitidine 75 mg (as ranitidine hydrochloride 84 mg) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	Acid reducer

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

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
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.

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

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
store at 20º-25ºC (68º-77ºF)
avoid excessive heat or humidity
this product is sodium and sugar free

hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Call 1-888-285-9159 or visit www.zantacotc.com

Zantac 75mg - 20ct Blister Packs
NDC: 0597-0122-27

Zantac 75mg - 80 ct. Bottle
NDC: 0597-0122-81

ranitidine TABLET, COATED

Product Information
Product Type	Human otc drug label	Item Code (Source)	NDC:0597-0122
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
ferric oxide red
titanium dioxide
triacetin

Product Characteristics
Color	Size	Imprint Code	Shape
PINK	3 mm	Z;75	PENTAGON (5 sided)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020520	2006-12-21

PLEASE, BE CAREFUL!

Be sure to consult your doctor before taking any medication!