healthy accents lansoprazole

Dosage form: capsule, delayed release
Ingredients: LANSOPRAZOLE 15mg
Labeler: DZA Brands LLC
NDC Code: 55316-117

DZA Brands, LLC Lansoprazole Delayed-Release Capsules 15mg Drug Facts

Active ingredient (in each capsule)

Lansoprazole 15 mg

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 lansoprazole

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.

Ask a doctor before use if you have
liver disease
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

Ask a doctor or pharmacist before use if you are taking
warfarin (blood-thinning medicine)
prescription antifungal or anti-yeast medicines
digoxin (heart medicine)
theophylline (asthma medicine)
tacrolimus (immune system medicine)
atazanavir (medicine for HIV infection)

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

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 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, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

swallow 1 capsule with a glass of water before eating in the morning
take every day for 14 days
do not take more than 1 capsule a day
swallow whole. Do not crush or chew capsules.
do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

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 before use. Heartburn in children may sometimes be caused by a serious condition.

Other information
read the directions, warnings and package insert before use
keep the carton and package insert. They contain important information.
store at 20-25˚C (68-77˚F)
keep product out of high heat and humidity
protect product from moisture

Inactive ingredients

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, 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

Questions or comments?

1-866-322-2439

Consumer Information

Lansoprazole Delayed-Release Capsules 15 mg

Acid Reducer

• May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

Please read the entire package insert before taking Lansoprazole Delayed-Release Capsules 15 mg.

Save for future reference.

How Lansoprazole Delayed-Release Capsules 15 mg Treats Your Frequent Heartburn

Lansoprazole Delayed-Release Capsules 15 mg stops acid production at the source – the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules 15 mg is taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking Lansoprazole Delayed-Release Capsules 15 mg

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules 15 mg is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take Lansoprazole Delayed-Release Capsules 15 mg every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole Delayed-Release Capsules 15 mg

Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.

Who Should NOT Take Lansoprazole Delayed-Release Capsules 15 mg

People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.

How to Take Lansoprazole Delayed-Release Capsules 15 mg

14-DAY Course of Treatment

Swallow 1 capsule with a glass of water before eating in the morning.
Take every day for 14 days.
Do not take more than 1 capsule a day.
Swallow whole. Do not crush or chew capsules.
Do not use for more than 14 days unless directed by your doctor.

When to Take Lansoprazole Delayed-Release Capsules 15 mg Again

You may repeat a 14-day course of therapy every 4 months.

When to Talk to Your Doctor

Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

Warnings and When to Ask Your Doctor

Allergy alert: Do not use if you are allergic to lansoprazole

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.

Ask a doctor before use if you have

liver disease
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

Ask a doctor or pharmacist before use if you are taking

warfarin (blood-thinning medicine)
prescription antifungal or anti-yeast medicines
digoxin (heart medicine)
theophylline (asthma medicine)
tacrolimus (immune system medicine)
atazanavir (medicine for HIV infection)

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

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)

Tips for Managing Heartburn

Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
Eat slowly and do not eat big meals.
Do not eat late at night or just before bedtime.
Do not lie flat or bend over soon after eating.
Raise the head of your bed.
Wear loose-fitting clothing around your stomach.
If you are overweight, lose weight.
If you smoke, quit smoking.

Clinical studies prove Lansoprazole Delayed-Release Capsules 15 mg effectively treats frequent heartburn

In three clinical studies, Lansoprazole Delayed-Release Capsules 15 mg was shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole Delayed-Release Capsules 15 mg is Sold

Lansoprazole Delayed-Release Capsules 15 mg is available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About Lansoprazole Delayed-Release Capsules 15 mg

Call 1-800-719-9260

:3T300 00 J3

Package/Label Principal Display Panel

Compare to Prevacid® 24 HR active ingredient

24 HR

Lansoprazole delayed-release capsules 15mg

acid reducer

May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

Clinically Proven To Treat Frequent Heartburn

actual size

42 capsules

three 14-day courses of treatment

HEALTHY ACCENTS LANSOPRAZOLE 
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-117
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
HYPROMELLOSES 
MANNITOL 
MEGLUMINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINK, GREENScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeL3T3
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-117-011 BOTTLE in 1 CARTON
114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
2NDC:55316-117-033 BOTTLE in 1 CARTON
214 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20231905/18/2012
Labeler - DZA Brands LLC (090322194)

Revised: 04/2014
 
DZA Brands LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)