Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
safeway acid reducer
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package/Label Principal Display Panel
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24 Hour
Acid Reducer
LANSOPRAZOLE DELAYED-RELEASE CAPSULES 15 mg
Acid Reducer
Treats Frequent Heartburn
• May take 1 to 4 days for full effect
• Sodium Free
Actual Size
14 CAPSULES
One 14-Day Course of Treatment
INDICATIONS & USAGE SECTION
Use
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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
DOSAGE & ADMINISTRATION SECTION
Directions
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adults 18 years of age and older
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this product is to be used once a day (every 24 hours), every day for 14 days
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it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
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swallow 1 capsule with a glass of water before eating in the morning
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take every day for 14 days
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do not take more than 1 capsule a day
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swallow whole. Do not crush or chew capsules.
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do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
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you may repeat a 14-day course every 4 months
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**do not take for more than 14 days or more often than every 4 months unless directed by a doctor**
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children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
WARNINGS SECTION
Warnings
Allergy alert:
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do not use if you are allergic to lansoprazole
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lansoprazole may cause severe skin reactions.
Symptoms may include:
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skin reddening
•
blisters
•
rash
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
**if you have:**
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trouble or pain swallowing food, vomiting with blood, or bloody or black stools
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heartburn with**lightheadedness, sweating or dizziness**
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chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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frequent**chest pain**
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have
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liver disease
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had heartburn over 3 months. This may be a sign of a more serious condition.
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frequent wheezing, particularly with heartburn
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unexplained weight loss
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nausea or vomiting
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stomach pain
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
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your heartburn continues or worsens
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you need to take this product for more than 14 days
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you need to take more than 1 course of treatment every 4 months
•
you get diarrhea
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you develop a rash or joint pain
If pregnant or breast-feeding,
ask a health care 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).
STORAGE AND HANDLING SECTION
Other information
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read the directions and warnings before use
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keep the carton. It contains important information.
•
store at 20-25°C (68-77°F)
•
keep product out of high heat and humidity
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protect product from moisture
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close cap tightly after use
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each capsule)
Lansoprazole 15 mg
OTC - PURPOSE SECTION
Purpose
Acid Reducer
OTC - QUESTIONS SECTION
Questions or comments?
1-800-719-9260
INACTIVE INGREDIENT SECTION
Inactive ingredients
D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide