OTC Medication Information: Sunmark Lansoprazole

SUNMARK LANSOPRAZOLE- lansoprazole capsule, delayed release
Strategic Sourcing Services LLC

Active ingredient (in each capsule)

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

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 care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison 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 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 and warnings before use
keep the carton. It contains 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

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

sunmark®

COMPARE TO PREVACID® 24 HR ACTIVE INGREDIENT

lansoprazole

Delayed Release Capsules, 15 mg

Acid Reducer

May take 1 to 4 days for full effect

Sodium Free

Treats Frequent Heartburn

24 HOUR

ACTUAL SIZE

14 CAPSULES

GLUTEN FREE

One 14-Day Course of Treatment

3t3-s1-lansoprazole
(click image for full-size original)
SUNMARK LANSOPRAZOLE
lansoprazole capsule, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0124
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. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MANNITOL
MEGLUMINE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK, GREEN Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 24HR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-0124-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (70677-0124-1)
2 NDC:70677-0124-3 3 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (70677-0124-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202319 12/13/2021
Labeler — Strategic Sourcing Services LLC (116956644)

Revised: 09/2022 Strategic Sourcing Services LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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