Famotidine Tablets, USP 10 mg and 20 mg
Famotidine by
Drug Labeling and Warnings
Famotidine by is a Otc medication manufactured, distributed, or labeled by Graviti Pharmaceuticals Private Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
FAMOTIDINE- famotidine tablet, film coated
Graviti Pharmaceuticals Private Limited
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Famotidine Tablets, USP 10 mg and 20 mg
ACTIVE INGREDIENT (IN EACH TABLET)
Drug Facts
Famotidine 10 mg
Maximum Strength
Drug Facts
Famotidine 20 mg
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
WARNINGS
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)
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
- 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
- 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.
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.
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.
| FAMOTIDINE
famotidine tablet, film coated |
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| FAMOTIDINE
famotidine tablet, film coated |
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| Labeler - Graviti Pharmaceuticals Private Limited (650884781) |
| Registrant - Graviti Pharmaceuticals Private Limited (650884781) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Graviti Pharmaceuticals Private Limited | 650884781 | MANUFACTURE(69844-097, 69844-098) , ANALYSIS(69844-097, 69844-098) | |
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