The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Zantac 360 (NDC 41167-0361). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Famotidine USP 10 mg ………………………………...............................................................................Acid reducer
Famotidine USP 20 mg ………………………………...............................................................................Acid reducer
■ 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
■ 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
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Allergy alert: Do not use if you are allergic to famotidine 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
■ 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
■ 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
■ kidney disease
■ 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
■ kidney disease
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
■ your heartburn continues or worsens
■ you need to take this product for more than 14 days
■ your heartburn continues or worsens
■ you need to take this product for more than 14 days
ask a health professional before use.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
■ adults and children 12 years and over:
■ to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
■ to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
■ do not use more than 2 tablets in 24 hours
■ children under 12 years: ask a doctor
■ adults and children 12 years and over:
■ to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
■ to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
■ do not use more than 2 tablets in 24 hours
■ children under 12 years: ask a doctor
■ read the directions and warnings before use
■ keep the carton. It contains important information.
■ store at 20-25°C (68-77°F)
■ protect from moisture
■ read the directions and warnings before use
■ keep the carton. It contains important information.
■ store at 20-25°C (68-77°F)
■ protect from moisture
carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide
carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide
call 1-800-633-1610 or visit www.zantacotc.com
Tips for Managing Heartburn
■ Do not lie flat or bend over after eating
■ Do not wear tight-fitting clothing around the stomach
■ Do not eat before bedtime
■ Raise the head of your bed
■ Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
■ Eat slowly and avoid big meals
■ If overweight, lose weight
■ Quit smoking
Zantac 360⁰
Famotidine Tablets 20 mg / Acid Reducer
Drug Facts
call 1-800-633-1610 or visit www.zantacotc.com
Tips for Managing Heartburn
■ Do not lie flat or bend over after eating
■ Do not wear tight-fitting clothing around the stomach
■ Do not eat before bedtime
■ Raise the head of your bed
■ Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
■ Eat slowly and avoid big meals
■ If overweight, lose weight
■ Quit smoking
Zantac
Famotidine Tablets USP 10 mg / Acid Reducer
360
30 Tablets
Principal Display Panelzantacfamotidine Tablets Usp 10 mg / Acid Reducer36030 Tablets (Zantac 360 01)
Zantac
Famotidine Tablets USP 20 mg / Acid Reducer
360
100 Tablets
Principal Display Panelzantacfamotidine Tablets Usp 20 mg / Acid Reducer360100 Tablets (Zantac 360 02)
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