Label: ZANTAC 360 COOL MINT- famotidine tablet, film coated
- NDC Code(s): 41167-0364-0, 41167-0364-1
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 28, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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.
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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
- Inactive ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZANTAC 360 COOL MINT
famotidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0364 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 STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color turquoise (Bluish-Green) Score no score Shape SQUARE (Rounded Square Biconvex) Size 4mm Flavor MINT (Cooling Mint Flavor Coating) Imprint Code Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0364-0 1 in 1 CARTON 12/01/2022 1 25 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41167-0364-1 1 in 1 CARTON 12/01/2022 2 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206531 12/01/2022 Labeler - Chattem, Inc. (003336013)