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| Product NDC Code | 69844-098 | ||||||||
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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 | 199047, 310273 |
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| Application Number | ANDA218461 | ||||||||
| Labeler Name | Graviti Pharmaceuticals Private Limited | ||||||||
| 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 (IN EACH TABLET) Original Strength Drug Facts Famotidine 10 mg Maximum Strength Drug Facts Famotidine 20 mg
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT carnauba wax, corn starch, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide. For 10 mg: iron oxide black and iron oxide red, For 20 mg: iron oxide yellow and iron oxide red.
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 STARCH, CORN HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 SODIUM STARCH GLYCOLATE TYPE A HYPROMELLOSE 2910 (15 MPA.S) HYDROXYPROPYL CELLULOSE, UNSPECIFIED TITANIUM DIOXIDE TALC CARNAUBA WAX FERRIC OXIDE RED FERROSOFERRIC OXIDE Light pink to pink rounded square biconvex 60 Famotidine Famotidine FAMOTIDINE FAMOTIDINE STARCH, CORN HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 SODIUM STARCH GLYCOLATE TYPE A HYPROMELLOSE 2910 (15 MPA.S) HYDROXYPROPYL CELLULOSE, UNSPECIFIED TITANIUM DIOXIDE TALC CARNAUBA WAX FERRIC OXIDE RED FERRIC OXIDE YELLOW Light yellow rounded square biconvex 35
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 Principal Display Panel - 10 mg Tablet: Container Label NDC 69844-097-01 Original Strength *Compare to the active ingredient in Pepcid AC ® Famotidine Tablet, USP 10 mg Acid Reducer Just One Tablet! Prevent & Relives Heartburn Due to Acid Indigestion 30 Tablets Marketed by Graviti Pharmaceuticals Inc. Made in India. Principal Display Panel - 10 mg Tablet: Carton Label NDC 69844-097-01 Original Strength *Compare to the active ingredient in Pepcid AC® Famotidine Tablet, USP 10 mg Acid Reducer Just One Tablet! Prevent & Relives Heartburn Due to Acid Indigestion 30's Tablets Bottles pack Marketed by Graviti Pharmaceuticals Inc. Made in India. Principal Display Panel - 10 mg Tablet: Carton Label NDC 69844-097-04 Original Strength *Compare to the active ingredient in Pepcid AC ® Famotidine Tablet, USP 10 mg Acid Reducer Just One Tablet! Prevent & Relives Heartburn Due to Acid Indigestion 10's Blister Pack Marketed by Graviti Pharmaceuticals Inc. Made in India. Principal Display Panel - 20 mg Tablets: Container Label NDC 69844-098-01 Maximum Strength *Compare to the active ingredient in Pepcid AC ® Famotidine Tablet, USP 20 mg Acid Reducer Just One Tablet! Prevent & Relives Heartburn Due to Acid Indigestion 30 Tablets Marketed by Graviti Pharmaceuticals Inc. Made in India. Principal Display Panel - 20 mg Tablets: Carton Label NDC 69844-098-01 Maximum Strength *Compare to the active ingredient in Pepcid AC® Famotidine Tablet, USP 20 mg Acid Reducer Just One Tablet! Prevent & Relives Heartburn Due to Acid Indigestion 30's Tablets Bottle Pack Marketed by Graviti Pharmaceuticals Inc. Made in India. Principal Display Panel - 20 mg Tablets: Carton Label NDC 69844-098-04 Maximum Strength *Compare to the active ingredient in Pepcid AC ® Famotidine Tablet, USP 20 mg Acid Reducer Just One Tablet! Prevent & Relives Heartburn Due to Acid Indigestion 10's Blister Pack Marketed by Graviti Pharmaceuticals Inc. Made in India. image 10 mg 30's bottels pack image image 20 mg 30's bottel pack image
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.DIRECTIONS Directions for 10 mg 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 for 20 mg 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 safety information
Information about safe use and handling of the product that may not have been specified in another field.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 FDA approved dissolution test specifications differ from USP.
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 toll-free weekdays 9 AM to 5 PM EST at 1-855-298-4506
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 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 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 a 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