LANSOPRAZOLE capsule, delayed release

Lansoprazole by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

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 medicines)
• atazanavir (medicine for HIV infection)
• methotrexate (arthritis medication)

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 Poison Control Center right away at 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 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° to 25°C (68° to 77°F)
  keep product out of high heat and humidity 
  protect product from moisture
  close cap tightly after use

Inactive ingredients

acetone, D&C Red #28, D&C Yellow #10, FD&C Blue #1, gelatin, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer type C, polyethylene glycol 4000, polysorbate 80, sugar spheres (which contain sucrose and starch), talc, titanium dioxide. Printing Ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, titanium dioxide

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday – Friday.

Principal Display Panel

Compare to the active ingredient in Prevacid® 24 HR*

HEB®

Treats Frequent Heartburn

Lansoprazole
Delayed-Release Capsules USP, 15 mg
Acid Reducer
24 Hour

May take 1 to 4 days for full effect
Sodium Free

Does not contain an ingredient derived from wheat, barley or rye

One 14-Day Course of Treatment
14 CAPSULES

INGREDIENTS AND APPEARANCE

LANSOPRAZOLE 
lansoprazole capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-448
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
ACETONE (UNII: 1364PS73AF)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SUCROSE (UNII: C151H8M554)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
ALCOHOL (UNII: 3K9958V90M)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)

Product Characteristics
Color	GREEN, PINK	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	L24HR
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-448-14	1 in 1 CARTON	12/03/2018	03/31/2021
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 37808-448-42	3 in 1 CARTON	12/14/2018	03/31/2021
2		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	ANDA203306	12/03/2018	03/31/2021

Labeler - HEB (007924756)