ZANTAC 360- famotidine tablet, film coated

Zantac 360 by

Drug Labeling and Warnings

Zantac 360 by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Zantac 360⁰

Famotidine Tablets 10 mg / Acid Reducer

Drug Facts

Active ingredient (in each tablet)

Famotidine USP 10 mg

Purpose

Acid reducer

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

Warnings

Allergy alert: Do not use if you are allergic to famotidine 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

■ kidney disease  

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

■ 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)

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 15to 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

■ 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

Questions or comments

call 1-800-633-1610or 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZANTAC 360 
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-214(NDC:41167-0361)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND (Square shaped Biconvex)	Size	5mm
Flavor		Imprint Code	CC;59
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-214-01	1 in 1 CARTON	08/01/2022
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 67751-214-02	2 in 1 CARTON	08/01/2022
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206531	08/01/2022

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-214) , repack(67751-214)