5c371d53-b93d-565e-bae6-1354c99d9035 — v3

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Version

v3

Effective date

June 22, 2009

Original packager

Sections captured

16

Identifiers

Document ID
1865b269-5b24-4cd4-bd8f-75d65bb7ce7b
Set ID
5c371d53-b93d-565e-bae6-1354c99d9035
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

ACTIVE INGREDIENT (IN EACH TABLET) Nizatidine 75 mg
Ask Doctor (1)

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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
Do Not Use (1)

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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
Dosage And Administration (1)

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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
Inactive Ingredient (1)

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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
Indications And Usage (1)

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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
Keep Out Of Reach Of Children (1)

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Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Package Label Principal Display Panel (1)

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PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton A XID AR ™ Nizatidine Tablets 75 mg Acid Reducer 50's Value Pack 50 TABLETS (50 DOSES) PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton
Pregnancy Or Breast Feeding (1)

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If pregnant or breast feeding, ask a health professional before use.
Purpose (1)

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PURPOSE Acid reducer
Questions (1)

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QUESTIONS OR COMMENTS? Call 1-800-555-2943 Monday through Friday 9 AM to 5 PM EST
Spl Patient Package Insert (1)

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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 Study A Study B Study C Study D
Spl Product Data Elements (1)

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AXID AR nizatidine NIZATIDINE NIZATIDINE SILICON DIOXIDE STARCH, CORN HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE RED TITANIUM DIOXIDE slightly glossy light yellow flaxen color slightly convex on sides Axid;AR
Spl Unclassified Section (2)

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DRUG FACTS

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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
Stop Use (1)

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Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days
Warnings (1)

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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