The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Distributed by:Little Pharma, Inc.New York, NY 10023
Active Ingredient (In Each Capsule)
*Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium, USP)
- 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
Do not use if you are allergic to omeprazole
Otc - Do Not Use
- Do not use if you have:trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizzinesschest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest painThese may be signs of a serious condition. See your doctor
Otc - Ask 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 heartburnunexplained weight lossnausea or vomitingstomach pain
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.
Otc - Stop Use
- Stop use and ask a doctor if:your heartburn continues or worsensyou need to take this product for more than 14 daysyou need to take more than 1 course of treatment every 4 monthsyou get diarrheayou 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).
- For adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatmentswallow 1 capsule with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 capsule a daydo not use for more than 14 days unless directed by your doctorswallow whole. Do not chew or crush capsules. Repeated 14-Day Courses (if needed)you may repeat a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 months unless directed by a doctorchildren under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
- 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
FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate
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