FDA Label for Famotidine 20 Mg

Active Ingredient (In Each Tablet)

For 10 mg:

Famotidine USP 10 mg

For 20 mg:

Famotidine USP 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

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)

Directions

For 10mg:

• adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o 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
o do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor

For 20 mg:

• adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o 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
o 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 Ingredients

For 10 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide

For 20 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

Questions Or Comments?

Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

• JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.



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





Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA




Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India 

Principal Display Panel

Famotidine Tablets USP, 10 mg

NDC: 25000-086-36

Famotidine Tablets USP 10 mg

30's (3 x 10's blister) count Carton Label

famo-10-mg-blister-ifc-3x10s - famo 10 mg blister ifc 3x10s

NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Bottle Label

NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Carton Label

NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Bottle Label

NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Carton Label

Famotidine Tablets USP, 20 mg

NDC: 25000-087-36

Famotidine Tablets USP 20 mg

30's (3 x 10's blister) count Carton Label

NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Bottle Label

NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Carton Label

NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Bottle Label

NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Carton Label