Label: LANSOPRAZOLE capsule, delayed release
- NDC Code(s): 70000-0612-1, 70000-0612-2, 70000-0612-3
- Packager: LEADER/ Cardinal Health 110, Inc.
- This is a repackaged label.
- Source NDC Code(s): 43598-109
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Use
-
Warnings
Allergy alert:
- do not use if you are allergic to lansoprazole
- lansoprazole may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use if you have:
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools.
- 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
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.
- 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.
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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
- 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
D&C Red 28, FD&C Blue No.1, FD&C Green 3, FD&C Red 40, gelatin, hydroxypropyl cellulose, iron oxide black, 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
- Questions or comments?
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Tips For Managing Heartburn
Tips For Managing Heartburn
• Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
• Eat slowly and do not eat big meals.
• Do not eat late at night or just before bedtime.
• Do not lie flat or bend over soon after eating.
• Raise the head of your bed.
• Wear loose-fitting clothing around your stomach.
• If you are overweight, lose weight.
• If you smoke, quit smoking.
- PRINCIPAL DISPLAY PANEL- Carton Label
- PRINCIPAL DISPLAY PANEL - Container Label
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INGREDIENTS AND APPEARANCE
LANSOPRAZOLE
lansoprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0612(NDC:43598-109) 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) MAGNESIUM CARBONATE (UNII: 0E53J927NA) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (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 BLUE (opaque cyan colored cap) , PINK (opaque pink 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:70000-0612-1 1 in 1 CARTON 10/26/2022 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70000-0612-3 3 in 1 CARTON 10/26/2022 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:70000-0612-2 2 in 1 CARTON 10/26/2022 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 ANDA202194 10/26/2022 Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)
