Label: HEARTBURN RELIEF 24 HOUR- lansoprazole capsule, delayed release
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Contains inactivated NDC Code(s)
NDC Code(s): 70253-019-14 - Packager: OUR FAMILY (Nash Finch Company)
- This is a repackaged label.
- Source NDC Code(s): 55648-140
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 16, 2013
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- Download DRUG LABEL INFO: PDF XML
- 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
- 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)
- Keep out of reach of children
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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 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. Patients should use the lowest dose and shortest duration of this therapy.
- 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?
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Principal Display Panel
Compare to the active ingredient in Prevacid® 24 HR*
*Prevacid® 24 HR is a registered trademark of Takeda Pharmaceuticals North America, Inc., and is used under license. ©2012 Novartis Consumer Health. Inc
HEARTBURN RELIEF 24 HOUR™
Lansoprazole Delayed- Release capsules, 15 mg
- may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
- Clinically proven to treat frequent heartburn
ACID REDUCER
Sodium Free
Product of India
KEEP OUTER 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 DARK BLUE TO BLACK GELATIN BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.
- Product Label
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INGREDIENTS AND APPEARANCE
HEARTBURN RELIEF 24 HOUR
lansoprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70253-019(NDC:55648-140) 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. 33 (UNII: 9DBA0SBB0L) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM CARBONATE (UNII: 0E53J927NA) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) Product Characteristics Color PINK, GREEN Score no score Shape CAPSULE Size 16mm Flavor Imprint Code w140 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70253-019-14 1 in 1 CARTON 1 14 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202727 03/27/2013 Labeler - OUR FAMILY (Nash Finch Company) (006962294) Registrant - P and L Development of New York Corporation (800014821)
