Label: LANSOPRAZOLE capsule, delayed release
- NDC Code(s): 0363-0739-27, 0363-0739-33, 0363-0739-52
- Packager: Walgreen Co
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 1, 2023
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
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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)
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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 days
- 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
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Inactive ingredients
FD&C Blue No. 2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide
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INGREDIENTS AND APPEARANCE
LANSOPRAZOLE
lansoprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0739 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) MAGNESIUM CARBONATE (UNII: 0E53J927NA) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (opaque pink colored cap) , GREEN (opaque green colored body) Score no score Shape CAPSULE Size 3mm Flavor Imprint Code RDY;398 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0739-27 2 in 1 PACKAGE, COMBINATION 05/18/2012 03/01/2023 1 NDC:0363-0739-52 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-0739-33 3 in 1 PACKAGE, COMBINATION 05/18/2012 03/01/2023 2 NDC:0363-0739-52 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 ANDA202194 05/18/2012 Labeler - Walgreen Co (008965063) Establishment Name Address ID/FEI Business Operations Dr.Reddy's Laboratories Limited (FTO III) 918608162 analysis(0363-0739) , manufacture(0363-0739)
