AXID AR description, usages, side effects, indications, overdosage, supplying and lots more!

AXID AR

Wyeth Consumer Healthcare

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Axid AR (nizatidine)

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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

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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.

PRODUCT PACKAGING

AXID AR

nizatidine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-2400
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
NIZATIDINE NIZATIDINE 75 mg

Product Characteristics

Color Size Imprint Code Shape
yellow (slightly glossy light yellow flaxen color) 15 mm Axid;AR OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE, PLASTIC
2 NDC:0573-2400-45 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020555 1996-05-09


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Be sure to consult your doctor before taking any medication!
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