Label: NEXIUM 24HR- esomeprazole magnesium capsule, delayed release
- NDC Code(s): 50090-1460-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0573-2450
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- INDICATIONS & USAGE
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WARNINGS
Warnings
Allergy alert:
- •
- Do not use if you are allergic to esomeprazole
- •
- Esomeprazole may cause severe skin reactions. Symptoms include:
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- skin reddening
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- blisters
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- rash
If an allergic reaction occurs, stop use and seek medical attention right away.
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
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- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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DOSAGE & ADMINISTRATION
Directions
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- 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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- may take 1 to 4 days for full effect
14-Day Course of Treatment Repeated 14-Day Courses (if needed)- •
- swallow 1 capsule 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 capsule a day
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- swallow whole. Do not crush or chew capsules.
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- do not use for more than 14 days unless directed by your doctor
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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 before use. Heartburn in children may sometimes be caused by a serious condition.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients (Nexium 24HR Capsules)
corn starch, D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate
Inactive Ingredients (Nexium 24HR ClearMinis)
carmine, corn starch, FD&C blue no. 2, FD&C blue no. 2 aluminum lake, FD&C red no. 3, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate
- QUESTIONS
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Additional Information
KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.
Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION”
or yellow band around the center of each capsule is broken or missing.
Tips for Managing Heartburn
- •
- Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
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- Eat slowly and do not eat big meals.
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- Do not eat late at night or just before bedtime.
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- Do not lie flat or bend over soon after eating.
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- Raise the head of your bed.
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- Wear loose-fitting clothing around your stomach.
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- If you are overweight, lose weight.
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- If you smoke, quit smoking.
Distributed by: GSK Consumer Healthcare,
Warren, NJ 07059
©2022 GSK group of companies or its licensor
Made in France
For most recent product information, visit www.Nexium24HR.com
Nexium is a registered trademark of AstraZeneca AB and is used under license.
- HOW SUPPLIED
- esomeprazole magnesium
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INGREDIENTS AND APPEARANCE
NEXIUM 24HR
esomeprazole magnesium capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1460(NDC:0573-2450) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FERRIC OXIDE RED (UNII: 1K09F3G675) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color PURPLE (amethyst) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code NEXIUM;20;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-1460-0 2 in 1 CARTON 11/28/2014 1 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 NDA204655 05/27/2014 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-1460)
