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| Product NDC Code | 58602-706 | ||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Famotidine |
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| Type | Generic | ||||||||||||||||||||||||||||||||||||||||||
| 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 | 310273 | ||||||||||||||||||||||||||||||||||||||||||
| Application Number | ANDA206531 | ||||||||||||||||||||||||||||||||||||||||||
| Labeler Name | Aurohealth LLC | ||||||||||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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 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 carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide and 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 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
Spl product data elements
Usually a list of ingredients in a drug product.Famotidine Famotidine FAMOTIDINE FAMOTIDINE CARNAUBA WAX STARCH, CORN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE FERRIC OXIDE RED SODIUM STARCH GLYCOLATE TYPE A CORN TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW Square shaped Biconvex CC;59
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.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Label) AUROHEALTH NDC 58602-706-14 MAXIMUM STRENGTH Famotidine Tablets USP 20 mg Acid Reducer Just One Tablet! Prevents & Relieves Heartburn Due to Acid Indigestion 50 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Carton Label) AUROHEALTH NDC 58602-706-14 *Compare to the Active Ingredient of Maximum Strength Pepcid ® AC MAXIMUM STRENGTH Famotidine Tablets USP 20 mg Acid Reducer Just One Tablet! Prevents & Relieves Heartburn Due to Acid Indigestion 50 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (50 Tablets, Container Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg Blister Carton 25 Tablets AUROHEALTH NDC 58602-706-62 *Compare to the Active Ingredient of Maximum Strength Pepcid ® AC MAXIMUM STRENGTH Famotidine Tablets USP 20 mg Acid Reducer Just One Tablet! Prevents & Relieves Heartburn Due to Acid Indigestion 25 Tablets famotidine-20mg-fig3.jpg
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
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 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.
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
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 (1-800-222-1222) right away.
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? call 1-855-274-4122 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 JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. Do not use if carton is open or if printed foil seal under bottle cap is open or torn. Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009
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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information read the directions and warnings before use keep the carton. It contains important information. store at 20° to 25°C (68° to 77°F) protect from moisture
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
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