Label: LANSOPRAZOLE tablet, orally disintegrating, delayed release
- NDC Code(s): 69842-507-55, 69842-507-74
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 8, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
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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
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- blisters
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- 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.
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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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- take 1 tablet before eating in the morning
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- do not crush or chew tablets
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- place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
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- take every day for 14 days
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- do not take more than 1 tablet a day
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- do not use for more than 14 days unless directed by your doctor
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- do not take this medicine with alcohol
- Repeated 14-Day Course (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.
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Other information
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- read the directions and warnings before use
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- keep the carton. It contains important information.
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- store at 20-25°C (68-77°F)
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- keep product out of high heat and humidity
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- protect product from moisture
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- take the tablet immediately after opening individual blister. Do not store the tablet outside the blister pack for future use.
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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?
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Package/Label Principal Display Panel
CVS Health®
Compare to the active ingredient in Prevacid® 24HR
Treats Frequent Heartburn
Lansoprazole
Melts in your mouth
dissolves without water
DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 15 mg
15
Actual Size
Acid Reducer
May take 1 to 4 days for full effect
24 HR
Strawberry Flavor
42 TABLETS
Three 14-day courses of treatment
MELTech®
Melts In Your Mouth
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INGREDIENTS AND APPEARANCE
LANSOPRAZOLE
lansoprazole tablet, orally disintegrating, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-507 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE 15 mg Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) CETYL ALCOHOL (UNII: 936JST6JCN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) COPOVIDONE K25-31 (UNII: D9C330MD8B) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) 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 Color WHITE (off white mottled) Score no score Shape ROUND Size 9mm Flavor STRAWBERRY Imprint Code 15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-507-55 3 in 1 CARTON 12/02/2017 1 14 in 1 CARTON 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69842-507-74 14 in 1 CARTON 01/04/2019 10/01/2022 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208025 12/02/2017 Labeler - CVS Pharmacy (062312574)
