FDA Label for Acid Reducer
View Indications, Usage & Precautions
- TIPS FOR MANAGING HEARTBURN
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE IF YOU HAVE:
- ASK A DOCTOR BEFORE USE IF YOU HAVE:
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING:
- STOP USE AND ASK A DOCTOR IF:
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 MG (14 TABLET BOTTLE)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 MG CONTAINER CARTON LABEL
Acid Reducer Product Label
The following document was submitted to the FDA by the labeler of this product Best Choice. 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.
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
Active Ingredient (In Each Tablet)
Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)
Purpose
Acid reducer
Use
- treats frequent heartburn (occurs 2 or more days a week)
- not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Warnings
Allergy alert:
Do not use if you are allergic to omeprazole
Do Not Use If You Have:
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- 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
These may be signs of a serious condition. See your doctor.
Ask A Doctor Before Use If You Have:
- had heartburn over 3 months. This may be a sign of a more serious condition.
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
Ask A Doctor Or Pharmacist Before Use If You Are Taking:
- warfarin, clopidogrel or cilostazol (blood-thinning medicines)
- prescription antifungal or anti-yeast medicines
- diazepam (anxiety medicine)
- digoxin (heart medicine)
- tacrolimus or mycophenolate mofetil (immune system medicines)
- prescription antiretrovirals (medicines for HIV infection)
- methotrexate (arthritis medicine)
Stop Use And Ask A Doctor If:
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- you need to take more than 1 course of treatment every 4 months
- you get diarrhea
- you develop a rash or joint pain
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 (1-800-222-1222) right away.
Directions
- for adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
- swallow 1 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- do not use for more than 14 days unless directed by your doctor
- swallow whole. Do not chew or crush tablets.
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
- children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
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) and protect from moisture
Inactive Ingredients
crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.
Questions?
Call 1-855-274-4122
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE. KANSAS CITY, KS 66106
MADE IN INDIA
Best Choice®
100% Guaranteed
www.bestchoicebrand.com
Code TS/DRUGS/22/2009
Package Label-Principal Display Panel - 20 Mg (14 Tablet Bottle)
NDC 63941-006-05
Acid Reducer Best
OMEPRAZOLE Choice®
DELAYED-RELEASE TABLETS 20 mg
24 HR 14 TABLETS
Treats Frequent Heartburn One 14-day course of treatment
May take 1 to 4 days for full effect
Package Label-Principal Display Panel - 20 Mg Container Carton Label
NDC 63941-006-05
Best
Choice®
COMPARE TO THE ACTIVE
INGREDIENT IN PRILOSEC OTC®*
Acid Reducer
OMEPRAZOLE
DELAYED-RELEASE
TABLETS 20 mg
24 HR
Treats FREQUENTS Heartburn
14 TABLETS
One 14-day course of treatment
May take 1 to 4 days for full effect
* Please review the disclaimer below.