Label: CURIST ACID RELIEF- famotidine 20 mg tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 26, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    curistrelief.com

    Important: Read all directions and warnings before use.

    Tamper Evident: do not use if imprinted inner safety seal is torn or missing

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Famotidine USP, 20 mg

  • PURPOSE

    Purpose

    Acid reducer

  • SPL UNCLASSIFIED SECTION

    (CONTINUED ON BACK OF LABEL)

    REV: 032-23-01

    NDC 72559-032-23

    Distributed by: Little Pharma, Inc.

    New York, NY 10023 | Made in India

    *Maximum strength famotidine tablet available over-the-counter (OTC) without a prescription

    PEEL HERE

  • INDICATIONS & USAGE

    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

    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 lighheadedness, sweating, or dizziness
    • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadness
    • 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)

  • DOSAGE & ADMINISTRATION

    • 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
  • STORAGE AND HANDLING

    Other information

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

    hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin

  • QUESTIONS

    Questions or comments?

    Call 1-844-243-1241 or email hi@curistrelief.com

  • SPL UNCLASSIFIED SECTION

    REV: 032-23-01

    STOP PEELING

  • PRINCIPAL DISPLAY PANEL

    curist

    Acid Relief

    Maximum Strength OTC*

    Famotidine Tablets USP, 20 mg

    Acid Reducer

    Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

    Maximum Strength Without a Prescription*

    300 Tablets

    label

  • INGREDIENTS AND APPEARANCE
    CURIST ACID RELIEF 
    famotidine 20 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code V;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-032-23300 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21582201/31/2024
    Labeler - Little Pharma, Inc. (074328189)
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!