ZANTAC 360- famotidine tablet, film coated 
Navajo Manufacturing Company Inc.

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Zantac 360

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

Zantac 360 Carton

ZANTAC 360 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-214(NDC:41167-0361)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
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
ColoryellowScoreno score
ShapeROUND (Square shaped Biconvex) Size5mm
FlavorImprint Code CC;59
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-214-011 in 1 CARTON08/01/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:67751-214-022 in 1 CARTON08/01/2022
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653108/01/2022
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-214) , repack(67751-214)

Revised: 4/2024
Document Id: 16276432-35b8-25ca-e063-6394a90a0115
Set id: e328c59c-baed-0e4e-e053-2995a90ab85c
Version: 2
Effective Time: 20240415
 
Navajo Manufacturing Company Inc.