Lansoprazole by Reliable 1 Laboratories LANSOPRAZOLE capsule

Lansoprazole by

Drug Labeling and Warnings

Lansoprazole by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each capsule)

Lansoprazole USP, 15 mg

Purpose

Acid reducer

Uses

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

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 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 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

FD&C Blue No.2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, 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?

call 1-888-375-3784

ASK 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 wheesing, particulary with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

PRINCIPAL DISPLAY PANEL

NDC: 69618-055-42

Compare to the active ingredient in Prevacid 24HR Capsules

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Reliable-1 Laboratories

Lansoprazole

Delayed-Release Capsules, USP 15 mg

Acid Reducer

24 HR

42 Capsules

Three 14-Day Cources of Treatment

INGREDIENTS AND APPEARANCE

LANSOPRAZOLE 
lansoprazole capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-055
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
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SUCROSE (UNII: C151H8M554)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GELATIN (UNII: 2G86QN327L)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (White to pale yellow colored enteric coated pellets filled in black color banded, Size “3” hard gelatin capsules with opaque pink colored cap and opaque green colored body)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	RDY;398
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-055-42	3 in 1 CARTON; Type 0: Not a Combination Product	09/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202194	09/20/2019

Labeler - Reliable 1 Laboratories (079718111)