Zantac 360

Zantac 360
SPL v2
SPL
SPL Set ID e328c59c-baed-0e4e-e053-2995a90ab85c
Route
ORAL
Published
Effective Date 2022-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Carnauba Wax Starch, Corn Magnesium Stearate Microcrystalline Cellulose Ferric Oxide Red Talc Titanium Dioxide Ferric Oxide Yellow Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose 2910 (5 Mpa.s) Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: CC;59 Shape: round Color: yellow Size: 5 mm Score: 1
Marketing Status
ANDA Active Since 2022-08-01

Description

Zantac 360⁰ Famotidine Tablets 10 mg / Acid Reducer Drug Facts

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Zantac 360⁰ Famotidine Tablets 10 mg / Acid Reducer Drug Facts

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

Active

Famotidine USP 10 mg

Section 42229-5

Zantac 360⁰

Famotidine Tablets 10 mg / Acid Reducer

Drug Facts

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Questions

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

Directions

■ 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

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

Other Information

■ 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      

Inactive Ingredients

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide

Ask A Doctor Before Us

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  

Principal Display Panel

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. (1-800-222-1222)

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.


Structured Label Content

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

Active

Famotidine USP 10 mg

Section 42229-5 (42229-5)

Zantac 360⁰

Famotidine Tablets 10 mg / Acid Reducer

Drug Facts

Purpose

Acid reducer

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Questions

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

Directions

■ 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

Do Not Use (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

Other Information (Other information)

■ 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      

Inactive Ingredients (Inactive ingredients)

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide

Ask A Doctor Before Us (Ask a doctor before us)

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  

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Acid reducers may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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