Zantac 360 Cool Mint

Zantac 360 Cool Mint
SPL v4
SPL
SPL Set ID 19fe7c6e-243c-4005-a63a-f8cac1ce55c8
Route
ORAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Starch, Corn Fd&c Blue No. 1 Aluminum Lake Fd&c Yellow No. 5 Aluminum Lake Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Corn Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Z Shape: square Color: turquoise Size: 4 mm Score: 1
Marketing Status
ANDA Active Since 2022-12-01 Until 2025-09-30

Description

Zantac 360° Cool Mint Tablets Famotidine 2 0 mg Drug Facts

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Zantac 360° Cool Mint Tablets Famotidine 2 0 mg Drug Facts

Use

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

Other

■ 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

■ contains FD&C yellow no. 5 (tartrazine) as a color additive

Section 42229-5

Zantac 360° Cool Mint Tablets Famotidine 2 0 mg

Drug Facts

Inactive

artificial flavors, corn starch, FD&C blue no. 1 aluminum lake, FD&C yellow no. 5 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose, talc, titanium dioxide

Warnings

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

Questions

call 1-866-844-2798 or visit www.zantac otc .com

Do not use if carton is open or if printed foil seal on bottle is broken or missing.

Keep carton as it contains important product information.

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 1 0   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

Active Ingredient

Famotidine USP 20 mg

Principal Display Panel

Zantac

Famotidine Tablets USP 20 mg / Acid Reducer

360

Cool Mint

50 Tablets

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 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

■ kidney disease

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

Use

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

Other

■ 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

■ contains FD&C yellow no. 5 (tartrazine) as a color additive

Section 42229-5 (42229-5)

Zantac 360° Cool Mint Tablets Famotidine 2 0 mg

Drug Facts

Purpose

Acid reducer

Inactive

artificial flavors, corn starch, FD&C blue no. 1 aluminum lake, FD&C yellow no. 5 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose, talc, titanium dioxide

Warnings

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

Questions

call 1-866-844-2798 or visit www.zantac otc .com

Do not use if carton is open or if printed foil seal on bottle is broken or missing.

Keep carton as it contains important product information.

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 1 0   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

Active Ingredient (Active ingredient)

Famotidine USP 20 mg

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Zantac

Famotidine Tablets USP 20 mg / Acid Reducer

360

Cool Mint

50 Tablets

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 Before Use If You Have (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

■ kidney disease

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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