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| Product NDC Code | 41167-0361 | ||||||||||||||||
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| 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 | ||||||||||||||||
| RxCUI drug identifier | 199047, 310273, 2607015, 2609246 |
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| Application Number | ANDA206531 | ||||||||||||||||
| Labeler Name | Chattem, 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 i ngredient (in each tablet ) Famotidine USP 10 mg
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 ■ 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 15 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
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 1 0 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 carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide
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.Use s ■ 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
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
Purpose
Information about the drug product’s indications for use.Purpose Acid reducer
Purpose Acid reducer
Spl product data elements
Usually a list of ingredients in a drug product.Zantac 360 Famotidine FAMOTIDINE FAMOTIDINE CARNAUBA WAX STARCH, CORN MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE FERRIC OXIDE RED TALC TITANIUM DIOXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) SODIUM STARCH GLYCOLATE TYPE A CORN HYPROMELLOSE 2910 (5 MPA.S) CC;58 biconvex Zantac 360 Famotidine FAMOTIDINE FAMOTIDINE CARNAUBA WAX STARCH, CORN MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE FERRIC OXIDE RED TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE 2910 (5 MPA.S) SODIUM STARCH GLYCOLATE TYPE A CORN CC;59 Square shaped 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.PRINCIPAL DISPLAY PANEL Zantac Famotidine Tablets USP 10 mg / Acid Reducer 360 30 Tablets PRINCIPAL DISPLAY PANEL Zantac Famotidine Tablets USP 10 mg / Acid Reducer 360 30 Tablets
PRINCIPAL DISPLAY PANEL Zantac Famotidine Tablets USP 20 mg / Acid Reducer 360 100 Tablets PRINCIPAL DISPLAY PANEL Zantac Famotidine Tablets USP 20 mg / Acid Reducer 360 100 Tablets
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.Zantac 360⁰ Famotidine Tablets 10 mg / Acid Reducer Drug Facts
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
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
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 us e 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 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 before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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 ■ 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
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)
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 c omments call 1-800-633-1610 or 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 Zantac 360⁰ Famotidine Tablets 20 mg / Acid Reducer Drug Facts
Questions or comments? call 1-800-633-1610 or 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
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 if ■ your heartburn continues or worsens ■ you need to take this product for more than 14 days
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 health professional before use.
If pregnant or breast-feeding, ask a health 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 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 us e 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. 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)
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. 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)
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