FDA Label for Famotidine

View Indications, Usage & Precautions

Famotidine Product Label

The following document was submitted to the FDA by the labeler of this product Glenmark Therapeutics Inc., Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

Distributed by: Glenmark Therapeutics Inc., USA
Mahwah, NJ 07430
Made in India
M.L. No.: 02/SKL/AP/2015/F/R

Revision: 04/22


Active Ingredient (In Each Tablet)



Famotidine, USP 10 mg and 20 mg


Purpose



Acid reducer


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

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

Otc - Ask Doctor/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 If



  • •your heartburn continues or worsens
  • •you need to take this product for more than 14 days

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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)


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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
    • •to prevent symptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
    • 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°C to 25°C (68°F to 77°F)
  • •protect from moisture

Inactive Ingredients



Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol


Questions Or Comments?



Call us at 1 (888) 721-7115 (toll-free)


Principal Display Panel



NDC 72657-112-90

Famotidine Tablets, USP 10mg

90 Tablets

NDC 72657-113-88

Famotidine Tablets, USP 20mg

85 Tablets


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