FDA Label for Zegerid Otc

View Indications, Usage & Precautions

OTC - ACTIVE INGREDIENT
USE
WARNINGS
DO NOT USE IF YOU HAVE:
ASK A DOCTOR BEFORE USE IF YOU HAVE
OTC - ASK DOCTOR/PHARMACIST
STOP USE AND ASK A DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zegerid Otc Product Label

The following document was submitted to the FDA by the labeler of this product Riley Consumer Care Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

Active Ingredients (in each capsule)	Purpose
Omeprazole 20 mg	Acid reducer
Sodium Bicarbonate 1100 mg	Allows absorption of this omeprazole product

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 omeprazole.
omeprazole may cause severe skin reactions
Symptoms may include:
- skin reddening
- blisters
- rash

Do Not Use If You Have:

trouble or pain swallowing food, vomiting with blood, or bloody or black stools
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

These may be signs of a serious condition. See your doctor.

Ask A Doctor Before Use If You Have

had heartburn over 3 months. This may be a sign of a more serious condition.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
a sodium-restricted diet.

Otc - 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 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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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 (1-800-222-1222).

Directions

for 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 at least 1 hour before eating in the morning
take every day for 14 days
do not take more than 1 capsule a day
do not chew or crush the capsule
do not open capsule and sprinkle on food
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
Heartburn in children may sometimes be caused by a serious condition.

Other Information

each capsule contains: sodium 303 mg
read the directions, warnings and accompanying label information before use
store at 20°- 25°C (68°-77°F)
tamper-evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with "Sealed for your protection" is missing, open or broken.
keep product out of high heat and humidity
protect product from moisture

Inactive Ingredients

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

Questions Or Comments?

Call 1-888-4-ZEG-OTC (1-888-493-4682) between: 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

Zegerid OTC design logo is a registered trademark of Riley Consumer Care, LLC d/b/a Carlin Consumer Health

Zegerid OTC is a registered trademark of Santarus, Inc.

Dist by: Riley Consumer Care, LLC d/b/a Carlin Consumer Health
New York, NY 10151

Package Label.Principal Display Panel

HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN

Zegerid OTC works differently from other OTC heartburn products, such as antacids and other
acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces
stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days.

TIIPS FOR MANAGING HEARTBURN
Do not lie flat or bend over after eating Do not eat late at night or just before bedtime Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables	Eat slowly and do not eat big meals If you are overweight, lose weight If you smoke, quit smoking Raise the head of your bed Wear loose-fitting clothing around your stomach

CLINICALLY PROVEN TO
Treat Frequent Heartburn

Zegerid
OTC^®

Omperazole 20mg / Acid Reducer
Sodium Bicarbonate 1100mg
/Allows Absorption of this
Omperazole Product

14 CAPSULES

One 14-Day Course of Treatment
MAY TAKE 1 TO 14 DAYS FOR FULL EFFECT

24 HOUR

1H9D5 XL C1

Carton - carton

* Please review the disclaimer below.

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