Saturday, September 15, 2012

Axid AR



nizatidine

Dosage Form: tablet, film coated
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






Wyeth Consumer Healthcare, Madison, NJ 07940



PRODUCT PACKAGING


The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.


Axid-AR


Nizatidine Tablets 75 mg


Acid Reducer


Relieves and Prevents Heartburn Associated with Acid Indigestion and Sour Stomach


50 Tablets (50 Doses)


Wyeth Consumer Healthcare, Madison, NJ 07940


U.S. Patent No. 4,375,547


Eli Lilly and Company owns the registered trademark Axid AR.


50’s Value Pack


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










Axid AR 
nizatidine  tablet, film coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-2400
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
nizatidine (nizatidine)nizatidine75 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Coloryellow (slightly glossy light yellow flaxen color)Scoreno score
ShapeOVAL (slightly convex on sides)Size15mm
FlavorImprint CodeAxid;AR
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-2400-451 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
150 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (0573-2400-45)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02055505/09/1996


Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 06/2009Wyeth Consumer Healthcare




More Axid AR resources


  • Axid AR Side Effects (in more detail)
  • Axid AR Use in Pregnancy & Breastfeeding
  • Axid AR Drug Interactions
  • Axid AR Support Group
  • 1 Review for Axid AR - Add your own review/rating


  • Axid AR MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nizatidine Professional Patient Advice (Wolters Kluwer)

  • Axid Monograph (AHFS DI)

  • Axid Consumer Overview



Compare Axid AR with other medications


  • Duodenal Ulcer
  • Duodenal Ulcer Prophylaxis
  • Erosive Esophagitis
  • GERD
  • Indigestion
  • Stomach Ulcer

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