Label: ZANTAC 360- famotidine tablet, film coated
- NDC Code(s): 67751-214-01, 67751-214-02
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 41167-0361
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 15, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- 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.
-
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
- Inactive ingredients
-
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
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INGREDIENTS AND APPEARANCE
ZANTAC 360
famotidine tablet, film coatedProduct 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)
