Label: PREVACID 24 HR- lansoprazole capsule, delayed release
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- NDC Code(s): 0067-6286-14, 0067-6286-28, 0067-6286-29, 0067-6286-42
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 7, 2019
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- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Use
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Warnings
Allergy alert: Do not use if you are allergic to lansoprazole
Do not use
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- 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
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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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- 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
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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
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- 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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- swallow 1 capsule with a glass of water before eating in the morning
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- take every day for 14 days
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- do not take more than 1 capsule a day
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- swallow whole. Do not crush or chew capsules
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- do not use for more than 14 days unless directed by your doctor
- Repeated 14-Day Courses (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.
- Other information
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Inactive ingredients
colloidal silicon dioxide, D&C red No. 28, FD&C blue No. 1, FD&C green No. 3, FD&C red No. 40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacryclic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar sphere, talc, titanium dioxide
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Principal Display Panel
NDC 0067-6286-42
Treats Frequent Heartburn
PREVACID 24HR
Lansoprazole delayed-release capsules 15 mg / acid reducer
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- May take 1 to 4 days for full effect
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- Sodium Free
42 CAPSULES
THREE 14-DAY COURSES OF TREATMENT
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2019 GSK group of companies or its licensor.
KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.
TAMPER-EVIDENT BOTTLE. DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” OR BLACK BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.
62000000031308
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INGREDIENTS AND APPEARANCE
PREVACID 24 HR
lansoprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-6286 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) MAGNESIUM CARBONATE (UNII: 0E53J927NA) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Teal) , PINK Score no score Shape CAPSULE Size 16mm Flavor Imprint Code P24HR Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-6286-14 1 in 1 CARTON 10/12/2009 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0067-6286-28 2 in 1 PACKAGE, COMBINATION 10/12/2009 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0067-6286-42 3 in 1 PACKAGE, COMBINATION 10/12/2009 3 14 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0067-6286-29 3 in 1 PACKAGE, COMBINATION 10/12/2009 05/03/2019 4 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 NDA NDA022327 10/12/2009 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
