omeprazole OMEPRAZOLE RITE AID FDA Approved 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
Generic: OMEPRAZOLE
Mfr: RITE AID FDA #7 OTC
FunFoxMeds bottle
Route
ORAL
Applications
ANDA210593

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) *Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)
Inactive Ingredients
Inactive Ingredients FD&C blue #1 FD&C red #40 ferrosoferric oxide gelatin hydroxypropyl cellulose hypromellose magnesium carbonate magnesium stearate methacrylic acid copolymer mono and diglycerides polyethylene glycol 6000 polysorbate 80 potassium hydroxide propylene glycol shellac sodium stearyl fumarate sugar spheres (starch and sucrose) talc titanium dioxide and triethyl citrate Questions? Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984
Strengths
20 mg 20.6 mg
Quantities
42 capsule 42 capsules 14 count
Treats Conditions
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
Pill Appearance
Shape: capsule Color: pink Imprint: RG49

Identifiers & Packaging

Container Type BOTTLE
UNII
426QFE7XLK
Packaging

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton NDC 11822-0061-4 TREATS FREQUENT HEARTBURN Compare to the active ingredient of Prilosec OTC ®† OMEPRAZOLE Delayed-release Capsules 20 mg* ACID REDUCER Mini Cap 40% Smaller Capsule 24 HR ACTUAL SIZE 42 CAPSULES THREE 14-DAY COURSES OF TREATMENT MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT TRIPLE PACK 3 X 14 COUNT BOTTLE INSIDE Principal Display Panel - 42 Capsule Bottle Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton NDC 11822-0061-4 TREATS FREQUENT HEARTBURN Compare to the active ingredient of Prilosec OTC ®† OMEPRAZOLE Delayed-release Capsules 20 mg* ACID REDUCER Mini Cap 40% Smaller Capsule 24 HR ACTUAL SIZE 42 CAPSULES THREE 14-DAY COURSES OF TREATMENT MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT TRIPLE PACK 3 X 14 COUNT BOTTLE INSIDE Principal Display Panel - 42 Capsule Bottle Carton

Overview

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

Indications & Usage

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

Dosage & Administration

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; 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 ■ do not use for more than 14 days unless directed by your doctor ■ swallow whole. Do not chew or crush capsules. 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 Safety Information ■ read the directions and warnings before use ■ keep the carton. It contains important information. ■ Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture

Warnings & Precautions
Warnings Allergy alert: Do not use if you are allergic to omeprazole 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 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 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).
Purpose

Purpose Acid reducer

Keep Out of Reach of Children

Keep Out of Reach of Children

Questions

Questions? Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984


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