Lansoprazole: Package Insert and Label Information

LANSOPRAZOLE- lansoprazole capsule, delayed release
Wockhardt USA LLC.

OTC — ACTIVE INGREDIENT SECTION

Lansoprazole 15 mg

OTC — PURPOSE SECTION

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 (immune system medicine)
  • atazanavir (medicine for HIV infection)

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

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 right away.

OTC — KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center 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

INACTIVE INGREDIENT

colloidal silicon dioxide, D & C Red No. 33, D & C Yellow No. 10, FD & C Blue No. 1, FD & C Red No. 40, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide

OTC — QUESTIONS

Call 1-800-346-6854

Poison Control Center:

Call 1-800-222-1222

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.130212

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64679-140-01

15 mg

14 C pack

15 mg label
(click image for full-size original)
LANSOPRAZOLE
lansoprazole capsule, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 15 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM CARBONATE
POLYETHYLENE GLYCOL 6000
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
Product Characteristics
Color PINK (Opaque dark pink cap) , GREEN (Opaque dark green body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code W;140
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-140-00 4500 CAPSULE, DELAYED RELEASE in 1 POUCH None
2 NDC:64679-140-01 1 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (64679-140-01)
3 NDC:64679-140-08 2 BOTTLE in 1 CARTON contains a BOTTLE
3 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (64679-140-08)
4 NDC:64679-140-09 3 BOTTLE in 1 CARTON contains a BOTTLE
4 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (64679-140-09)
5 NDC:64679-140-07 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (64679-140-07)
6 NDC:64679-140-10 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (64679-140-10)
7 NDC:64679-140-11 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (64679-140-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202727 05/18/2012
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt USA LLC. (170508365)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 916489953 ANALYSIS (64679-140), LABEL (64679-140), MANUFACTURE (64679-140), PACK (64679-140)

Revised: 11/2019 Wockhardt USA LLC.

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