FDA Label for Famotidine

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

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

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

10 mg:
• to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating food or drinking beverages that cause heartburn

20 mg:

• to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes beforeeating 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° to 25°C (68° to 77°F)
• protect from moisture

Inactive Ingredients

10 mg:
carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide.

20 mg:

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, red iron oxide and yellow iron oxide.

Questions Or Comments?

1-888-375-3784
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

Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Principal Display Panel

Famotidine Tablets USP 10 mg - 30s container label
   

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Famotidine Tablets USP 10 mg - 30s container carton label
   

Famotidine Tablets USP 20 mg - 50s container label
  

Famotidine Tablets USP 20 mg - 50s container carton label