Label: LANSOPRAZOLE 24 HR- lansoprazole capsule, delayed release
- NDC Code(s): 62175-515-12, 62175-515-24, 62175-515-52
- Packager: Lannett Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated September 10, 2020
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- Active ingredient
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 Course of Treatment (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
ammonium hydroxide, black iron oxide, butyl alcohol, dehydrated alcohol, FD&C Blue #1, FD&C Red #40, gelatin, hypromellose, iron oxide yellow, isopropyl alcohol, magnesium carbonate, mannitol, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, sodium starch glycolate, sugar sphere, talc, titanium dioxide
- Questions or Comments
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
LANSOPRAZOLE 24 HR
lansoprazole capsule, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62175-515 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 AMMONIA (UNII: 5138Q19F1X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM CARBONATE (UNII: 0E53J927NA) MANNITOL (UNII: 3OWL53L36A) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN (opaque green cap) , WHITE (opague white body) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code KU;515 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62175-515-24 1 in 1 CARTON 09/29/2017 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:62175-515-12 2 in 1 PACKAGE, COMBINATION 09/29/2017 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:62175-515-52 3 in 1 PACKAGE, COMBINATION 09/29/2017 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 ANDA207157 09/29/2017 Labeler - Lannett Company, Inc. (006422406)