AXID AR- nizatidine tablet, film coated 
Wyeth Consumer Healthcare LLC

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Axid AR (nizatidine)

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

Nizatidine 75 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 food and beverages

WARNINGS

Allergy alert:

Do not use if you are allergic to nizatidine 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

  • 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

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

DIRECTIONS

  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a full glass of water
    • to prevent symptoms, swallow 1 tablet with a full glass of water right before eating or up to 60 minutes before consuming food and beverages that cause you heartburn
    • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

OTHER INFORMATION

  • store at 20-25°C (68-77°F)
  • protect from light
  • replace cap tightly after opening bottle
  • keep the carton and package insert. They contain important information

INACTIVE INGREDIENTS

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pharmaceutical ink, polyethylene glycol, pregelatinized starch, propylene glycol, synthetic iron oxides, titanium dioxide

QUESTIONS OR COMMENTS?

Call 1-800-555-2943 Monday through Friday 9 AM to 5 PM EST

PRODUCT INFORMATION SHEET

PLEASE SAVE THIS SHEET FOR FUTURE USE

Bottle sealed with printed foil under cap. Do Not Use if foil imprinted "SEALED FOR YOUR PROTECTION" is open or torn.

  • AXID AR is a non-prescription medicine that contains nizatidine, an ingredient that doctors have prescribed for years.
  • AXID AR works by reducing the production of stomach acid that can cause heartburn.
  • In clinical studies, AXID AR was significantly better than placebo in relieving and preventing heartburn symptoms.

Heartburn: a problem that can interfere with your lifestyle

The stomach normally produces acid, especially following eating and drinking. Sometimes acid backing up into the esophagus can cause a burning pain and discomfort. This pain and discomfort is commonly known as heartburn.

When taken as directed, AXID AR relieves and/or prevents heartburn.

Tips for managing heartburn

  • Avoid lying down flat or bending over soon after eating.
  • Avoid eating late at night, or just before bedtime.
  • Avoid certain foods or beverages more likely to cause heartburn, such as rich, spicy, fried foods; chocolate, caffeine, alcohol; even some fruits and vegetables.
  • Eat slowly and do not eat big meals.
  • If you are overweight, lose weight.
  • If you smoke, stop or cut down.
  • Elevate the head of your bed.
  • Avoid wearing tight fitting clothing around your stomach.

Studies

Study A
Study B
Study C
Study D

Wyeth Consumer Healthcare, Madison, NJ 07940

PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

AXID
AR

Nizatidine Tablets 75 mg
Acid Reducer

50's Value Pack

50 TABLETS (50 DOSES)

PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton
AXID AR 
nizatidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2400
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIZATIDINE (UNII: P41PML4GHR) (NIZATIDINE - UNII:P41PML4GHR) NIZATIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (slightly glossy light yellow flaxen color) Scoreno score
ShapeOVAL (slightly convex on sides) Size15mm
FlavorImprint Code Axid;AR
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-2400-451 in 1 CARTON05/09/199608/31/2012
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02055505/09/199608/31/2012
Labeler - Wyeth Consumer Healthcare LLC (828831730)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-2400) , LABEL(0573-2400) , MANUFACTURE(0573-2400) , PACK(0573-2400)

Revised: 6/2009
 
Wyeth Consumer Healthcare LLC