Label: LANSOPRAZOLE capsule, delayed release
- NDC Code(s): 11822-3374-5, 11822-3374-7
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 12, 2022
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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 a prescription drug. Acid reducers may interact with certain prescription drug
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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
black iron oxide,colloidal silicon dioxide, corn starch, FD&C Blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer type C, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide, yellow iron oxide
- Questions or comments?
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Principal Display Panel
†Compare to the active ingredient in Prevacid® 24HR*
LANSOPRAZOLE
Delayed-Release Capsules USP, 15 mg
24HR
Acid Reducer
TREATS FREQUENT HEARTBURN
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
CAPSULES
†This product is not manufactured or distributed by Takeda Pharmaceuticals U.S.A., Inc., owner of the registered trademark Prevacid®, or by Perrigo Company plc, distributor of the Prevacid® 24HR product.
TAMPER EVIDENT: DO NOT USE IF TAMPER-EVIDENT INNER SEAL OR BLACK BAND AROUND THE CENTER OF EACH CAPSULES IS BROKEN OR MISSING.
KEEP OUTER CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
- Package Label
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INGREDIENTS AND APPEARANCE
LANSOPRAZOLE
lansoprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-3374 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) MAGNESIUM CARBONATE (UNII: 0E53J927NA) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color pink, green Score no score Shape CAPSULE Size 18mm Flavor Imprint Code MYL;LD15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-3374-5 1 in 1 CARTON 11/29/2019 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:11822-3374-7 3 in 1 BOX 11/29/2019 2 14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203187 11/29/2019 Labeler - Rite Aid Corporation (014578892)
