Active Ingredient
Active ingredient (in each tablet)
Famotidine USP 20 mg
Zantac 360 Tablet, Film Coated
FDA Label NDC 66715-9758
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc for the product Zantac 360 (NDC 66715-9758). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, alergy alert, do not use, ask a doctor before use, ask a doctor or pharmacist, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
Acid reducer
Uses
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 foods and beverages
Alergy Alert
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do Not Use
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
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
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
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
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
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
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
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?
Questions or comments?
call
1-800-633-1610 or visit
www.zantacotc.com
Other
Product manufactured for:
Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219
©2021 Made in India
Product repackaged and distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW, Cedar Rapids, IA 52404
1-877-507-6516 (M-F 8AM-4:30PM CST)
www.lildrugstore.com 97585C-US-04-21
Pdp/Package
NEW FORMULA MAXIMUM STRENGTH
See New Warnings
Zantac
360°™
Famotidine Tablets USP 20 mg / Acid Reducer
JUST ONE TABLET
PREVENTS
& RELIEVES
HEARTBURN
DUE TO ACID
INDIGESTION
[tablet image]
Actual Size
5 Tablets
(5 Doses)
[Lil' Drug Store logo]
* Please review the disclaimer below.
