FDA Label for Famotidine - Acid Controller
View Indications, Usage & Precautions
Famotidine - Acid Controller Product Label
The following document was submitted to the FDA by the labeler of this product Ohm Laboratories Inc.. 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.
Active Ingredient (In Each Tablet)
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
• with other acid reducers• if you have kidney disease, except under the advice and supervision of a doctor.• 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.
Ask A Doctor Before Use If You Have
• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss• nausea or vomiting• stomach pain• 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
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 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
• store at 20° to 25° C (68° to 77° F)• protect from moisture• read the directions and warnings before use• keep the carton. It contains important information.• TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. (for blister carton)• TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for bottle carton/label)• TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for SAL/extended label)
Inactive Ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide
Questions?
call 1-800-406-7984
Patient Information
JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
See end panel for batch number and expiration date. (for carton only)
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
Principal Display Panel
†Compare to the active ingredient of Maximum Strength Pepcid AC®.
NDC 51660-036-26
ohm®
MAXIMUM STRENGTH
Acid Controller
Famotidine Tablets, USP 20 mg
Acid Reducer
Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion
25 TABLETS
Distributed by: Ohm Laboratories Inc.
5142565/R0517
25's Blister Carton
* Please review the disclaimer below.