Zantac 360

Label at a glance#

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-633-1610

Websitewww.zantacotc.comwww.zantacotc.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Allergy Alert

SPL UNCLASSIFIED SECTION

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

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• your heartburn continues or worsens
• you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

STORAGE AND HANDLING SECTION

• read the directions and warnings before use
• store at 20-25°C (68-77°F)
• protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

call 1-800-633-1610 or visit www.zantacotc.com

SPL UNCLASSIFIED SECTION

Product Repackaged and Distributed
with permission of manufacturer by:
Select Corporation Carrollton, TX 75007

PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA
MAXIMUM STRENGTH
See New Warnings

Zantac
360°_™
Famotidine Tablets USP 20 mg/Acid Reducer

JUST ONE TABLET
PREVENTS
& RELIEVES
HEARTBURN
DUE TO ACID
INDIGESTION

1 TABLET
Actual Size

2111926095.A

DailyMed Pharmacologic Classes#

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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Zantac 360
• famotidine
• carnauba wax
• STARCH, CORN
• magnesium stearate
• microcrystalline cellulose
• ferric oxide red
• talc
• titanium dioxide
• hydroxypropyl cellulose (1600000 WAMW)
• SODIUM STARCH GLYCOLATE TYPE A CORN
• hypromellose 2910 (5 mpa.s)

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

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Product history page 1 of 3 · 86 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.