Label: LANSOPRAZOLE capsule, delayed release
- NDC Code(s): 0363-1212-01, 0363-1212-02, 0363-1212-03
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated September 5, 2023
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- Active ingredient (in each capsule)
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
- 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
- Inactive ingredients
- Questions or comments?
Package/Label Principal Display Panel
Treats frequent heartburn
WALGREENS PHARAMCIST COMMENDED
Compare to the active ingredient in Prevacid® 24 HR
DELAYED RELEASE CAPSULES, 15 mg / ACID REDUCER
• May take 1 to 4 days for full effect
• Sodium free
THREE 14-DAY COURSES OF TREATMENT
INGREDIENTS AND APPEARANCE
lansoprazole capsule, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1212 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 D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) MANNITOL (UNII: 3OWL53L36A) MEGLUMINE (UNII: 6HG8UB2MUY) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK, GREEN Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 24HR Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1212-01 1 in 1 CARTON 06/07/2021 11/01/2023 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-1212-02 2 in 1 CARTON 06/07/2021 10/31/2023 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-1212-03 3 in 1 CARTON 06/07/2021 11/30/2023 3 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202319 06/07/2021 11/30/2023 Labeler - Walgreen Company (008965063)