FDA Label for Acid Reducer
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS/COMMENTS
- PRINCIPAL DISPLAY PANEL
Acid Reducer Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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(S)
Famotidine USP 20 mg
Purpose
Acid reducer
Use(S)
- 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
- explained 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 Breastfeeding,
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
- read the directions and warnings before use
- do not use if imprinted safety seal under cap is broken or
missing n store at 20°-25°C (68°-77°F) - protect from moisture
Inactive Ingredients
carnauba wax, corn starch, hydroxypropyl cellulose,
hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate, talc, titanium dioxide
Questions/Comments
Call 1-888-952-0050 Monday through Friday
9AM − 5PM EST
Principal Display Panel
Acid Reducer
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