Label: ZANTAC 360- famotidine tablet, film coated

  • NDC Code(s): 41167-0360-2, 41167-0361-0, 41167-0361-1, 41167-0361-2, view more
    41167-0361-4, 41167-0361-6, 41167-0361-8, 41167-0361-9
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 17, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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 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

  • 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 1-800-633-1610 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

    Zantac 360⁰

    Famotidine Tablets 20 mg / Acid Reducer

    Drug Facts

  • Active ingredient (in each tablet)

    Famotidine USP 20 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 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

    ■ 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, yellow iron oxide

  • Questions or comments?

    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

  • PRINCIPAL DISPLAY PANEL

    Zantac
    Famotidine Tablets USP 10 mg / Acid Reducer
    360
    30 Tablets

    PRINCIPAL DISPLAY PANEL Zantac Famotidine Tablets USP 10 mg / Acid Reducer 360 30 Tablets

  • PRINCIPAL DISPLAY PANEL

    Zantac
    Famotidine Tablets USP 20 mg / Acid Reducer
    360
    100 Tablets

    PRINCIPAL DISPLAY PANEL Zantac Famotidine Tablets USP 20 mg / Acid Reducer 360 100 Tablets

  • INGREDIENTS AND APPEARANCE
    ZANTAC 360 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0360
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 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)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUND (biconvex) Size5mm
    FlavorImprint Code CC;58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0360-21 in 1 CARTON04/12/2021
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653104/12/2021
    ZANTAC 360 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:41167-0361-01 in 1 CARTON04/12/2021
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0361-21 in 1 CARTON04/12/2021
    225 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41167-0361-41 in 1 CARTON04/12/2021
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41167-0361-92 in 1 CELLO PACK04/12/2021
    470 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:41167-0361-61 in 1 CARTON04/12/2021
    590 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:41167-0361-81 in 1 CARTON04/12/2021
    6100 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:41167-0361-11 in 1 CARTON04/12/2021
    71 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653104/12/2021
    Labeler - Chattem, Inc. (003336013)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!