LANSOPRAZOLE- lansoprazole tablet, orally disintegrating, delayed release 
Walgreen Company

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Walgreen Co. Lansoprazole Drug Facts

Active ingredient (in each tablet)

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 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
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 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).

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

take 1 tablet before eating in the morning
do not crush or chew tablets
place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
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
do not take this medicine with alcohol

Repeated 14-Day Course (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

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

Consumer Information

Treats Frequent Heartburn

Lansoprazole

Delayed Release

Orally Disintegrating Tablets 15 mg

acid reducer

• May take 1 to 4 days for full effect

Please read the entire package insert before taking

Lansoprazole Delayed Release Orally Disintegrating Tablets.

Save for future reference.

How Lansoprazole delayed release orally disintegrating tablets Treats Your Frequent Heartburn

Lansoprazole delayed release orally disintegrating tablets stops acid production at the source - the pumps that release acid into the stomach. Lansoprazole delayed release orally disintegrating tablet is taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking Lansoprazole delayed release orally disintegrating tablets

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole delayed release orally disintegrating tablets in the morning before eating. Lansoprazole 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 orally disintegrating tablets every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole delayed release orally disintegrating tablets

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 orally disintegrating tablets

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

How to Take Lansoprazole delayed release orally disintegrating tablets

14-DAY Course of Treatment

Take 1 tablet before eating in the morning.
Do not crush or chew tablets.
Place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
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.
Do not take this medicine with alcohol.

When to Take Lansoprazole delayed release orally disintegrating tablets 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 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
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 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).

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 that lansoprazole effectively treats frequent heartburn

In three clinical studies, lansoprazole was shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole delayed release orally disintegrating tablets is Sold

This medicine is available in 14 tablet, 28 tablet and 42 tablet 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 orally disintegrating tablets

Call 1-800-719-9260

weekdays 7:30 AM to 5:00 PM EST

Made in Israel

Manufactured by:

Dexcel Pharma Technologies Ltd

10 Hakidma Street, Yokneam 2069200, Israel

:8U100 00 J3

1249460078-B

Package/Label Principal Display Panel

Treats frequent heartburn

Walgreens

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Melts In Your Mouth

Orally Disintegrating Tablets

Lansoprazole

DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 15 mg / ACID REDUCER

24 HOUR

● May take 1 to 4 days for full effect

● Melts in your mouth; dissolves without water

42 TABLETS

THREE 14-DAY COURSES OF TREATMENT

ACTUAL SIZE

ORALLY DISINTEGRATING TABLETS

Strawberry flavor

lansoprazole-image
LANSOPRAZOLE 
lansoprazole tablet, orally disintegrating, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1419
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTITOL (UNII: D65DG142WK)  
MANNITOL (UNII: 3OWL53L36A)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (off white mottled) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1419-553 in 1 CARTON05/25/2017
114 in 1 CARTON
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0363-1419-741 in 1 CARTON05/25/201705/01/2019
214 in 1 CARTON
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20802505/25/2017
Labeler - Walgreen Company (008965063)

Revised: 5/2023
Document Id: 3d9b0e95-13a6-4c6f-a8f9-ad13c74b380b
Set id: a72f92cc-db49-40ef-a249-6b7c50dc8ef2
Version: 4
Effective Time: 20230502
 
Walgreen Company