LANSOPRAZOLE capsule, delayed release

Lansoprazole by

Drug Labeling and Warnings

Lansoprazole by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Lansoprazole USP, 15 mg

Purpose

Acid reducer

Use

• treats frequent heartburn (occurs 2 or more days a week)
• not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

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 or mycophenolate mofetil (immune system medicine)
• atazanavir (medicine for HIV infection)
• methotrexate (arthritis medicine)

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

• read the directions, warnings and package insert before use
• keep the carton and package insert. They contain important information.
• store at 20°-25°C (68°-77°F)
• keep product out of high heat and humidity
• protect product from moisture
• close cap tightly after use

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 dispersion, 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?

Call 1-800-645-2158

Principal Display Panel

Compare to the active ingredient in Prevacid® 24HR†

Lansoprazole Delayed-Release

Capsules USP, 15 mg

Acid Reducer

Treats Frequent Heartburn

• May take 1 to 4 days for full effect
• Sodium free

Capsules

Three 14-day Course of Treatment

†This product is not manufactured or distributed by Takeda Pharmaceuticals North America, Inc., owner of the registered trademark Prevacid®, or by GSK Consumer Healthcare, distributor of the Prevacid® 24HR product.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP 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:

Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI48152

www.rugbylaboratories.com

Package Label

RUGBY Lansoprazole Delayed-Release Capsules

INGREDIENTS AND APPEARANCE

LANSOPRAZOLE 
lansoprazole capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1236
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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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: 0536-1236-13	3 in 1 BOX	05/31/2019
1		14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0536-1236-88	1 in 1 BOX	05/31/2019
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	05/31/2019

Labeler - Rugby Laboratories, Inc. (079246066)