Label: CARE ONE OMEPRAZOLE- omeprazole tablet, delayed release
- NDC Code(s): 41520-915-03, 41520-915-30, 41520-915-55, 41520-915-74
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated May 20, 2019
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Allergy alert: Do not use if you are allergic to omeprazole
Do not use if you have:
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- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
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- heartburn with lightheadedness, sweating or dizziness
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- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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- frequent chest pain
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have:
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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Directions
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- for adults 18 years of age and older
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- this product is to be used once a day (every 24 hours), every day for 14 days
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- 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
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- swallow 1 tablet with a glass of water before eating in the morning
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- take every day for 14 days
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- do not take more than 1 tablet a day
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- do not use for more than 14 days unless directed by your doctor
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- swallow whole. Do not chew or crush tablets
- Repeated 14-Day Courses (if needed)
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- you may repeat a 14-day course every 4 months
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- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
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- children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CARE ONE OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-915 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MONOETHANOLAMINE (UNII: 5KV86114PT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color BROWN Score no score Shape OVAL Size 12mm Flavor Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-915-74 14 in 1 CARTON 02/29/2008 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41520-915-30 2 in 1 CARTON 02/29/2008 2 14 in 1 CARTON 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:41520-915-55 3 in 1 CARTON 02/29/2008 3 14 in 1 CARTON 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:41520-915-03 3 in 1 CARTON 04/26/2018 4 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022032 02/29/2008 Labeler - American Sales Company (809183973)