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| Product NDC Code | 66715-9758 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Zantac 360 |
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| Type | Brand | ||||||
| Pharm Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, FILM COATED | ||||||
| Application Number | ANDA206531 | ||||||
| Labeler Name | Lil' Drug Store Products, Inc | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active ingredient (in each tablet) Famotidine USP 20 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Purpose Acid reducer
Spl product data elements
Usually a list of ingredients in a drug product.Zantac 360 Famotidine tablet, film-coated MAGNESIUM STEARATE TALC FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (5 MPA.S) SODIUM STARCH GLYCOLATE TYPE A CORN CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE (1600000 WAMW) STARCH, CORN TITANIUM DIOXIDE FAMOTIDINE FAMOTIDINE FERRIC OXIDE RED CC;59 Rounded edges; biconvex Zantac 360, Travel BASIX Famotidine tablet, film-coated MAGNESIUM STEARATE TALC FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (5 MPA.S) SODIUM STARCH GLYCOLATE TYPE A CORN CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE (1600000 WAMW) STARCH, CORN TITANIUM DIOXIDE FAMOTIDINE FAMOTIDINE FERRIC OXIDE RED CC;59 Rounded edges; biconvex
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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] PDP
Zantac 360°™, Lil' Drug Store ® - 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 2 Tablets (2 Doses) [Lil' Drug Store logo] PDP/Package
Zantac 360°™, Travel BASIX NEW FORMULA See New Warnings MAXIMUM STRENGTH Zantac 360°™ Famotidine Tablets USP 20 mg / Acid Reducer JUST ONE TABLET PREVENTS & RELIEVES HEARTBURN DUE TO ACID INDIGESTION [tablet image] Actual Size 2 Tablets [Travel BASIX logo] PDP/Package
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information Other information read the directions and warnings before use keep the carton. It contains important information. store at 20º-25ºC (68º-77ºF) protect from moisture
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Questions or comments? call 1-800-633-1610 or visit www.zantacotc.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a healthcare professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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 If pregnant or breast-feeding, ask a healthcare 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).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API