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| Product NDC Code | 0135-0098 | ||||
|---|---|---|---|---|---|
| Drug Name | Gaviscon extra strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 212978, 308072, 731000, 1086458 |
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| Application Number | part331 | ||||
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each tablet) (Extra Strength) Aluminum hydroxide 160mg Magnesium carbonate 105mg
Active ingredients (in each tablet) (Regular Strength) Dried aluminum hydroxide gel 80mg Magnesium trisilicate 14.2mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions (Extra Strength) • chew 2-4 tablets four times a day or as directed by a doctor • take after meals and at bedtime or as needed • for best results follow by a half glass of water or other liquid • DO NOT SWALLOW WHOLE
Directions (Regular Strength) • do not swallow tablets whole • chew 2 to 4 tablets after meals and at bedtime as needed (up to 4 times a day) or as directed by a doctor. For best results, drink a half glass of water or other liquid after each dose. • do not take more than 16 tablets in 24 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (Extra Strength) alginic acid, calcium stearate, flavor, sodium bicarbonate, and sucrose. May contain stearic acid. Contains sorbitol or mannitol. May contain starch.
Inactive ingredients (Extra Strength Cherry) acesulfame k, alginic acid, artificial flavor, calcium stearate, corn starch, corn syrup solids, mannitol, sodium bicarbonate, stearic acid, sucrose
Inactive ingredients (Regular Strength) alginic acid, calcium stearate, flavor, sodium bicarbonate, starch (may contain corn starch) and sucrose
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses (Extra Strength) relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms
Uses (Regular Strength) temporarily relieves symptoms of: • heartburn and acid indigestion due to acid reflux
Purpose
Information about the drug product’s indications for use.Purpose Antacid Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Gaviscon Extra Strength aluminum hydroxide and magnesium carbonate ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM CARBONATE CARBONATE ION ALGINIC ACID CALCIUM STEARATE SODIUM BICARBONATE SUCROSE STEARIC ACID SORBITOL MANNITOL STARCH, CORN GAVISCON Vanilla Mint Gaviscon Extra Strength aluminum hydroxide and magnesium carbonate ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM CARBONATE CARBONATE ION ACESULFAME POTASSIUM ALGINIC ACID CALCIUM STEARATE STARCH, CORN CORN SYRUP MANNITOL SODIUM BICARBONATE STEARIC ACID SUCROSE GAVISCON Gaviscon Regular Strength aluminum hydroxide and magnesium trisilicate ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM TRISILICATE MAGNESIUM CATION ALGINIC ACID CALCIUM STEARATE SODIUM BICARBONATE STARCH, CORN SUCROSE GAVISCON Vanilla Mint
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel NDC 0135-0098-26 Gaviscon ® EXTRA STRENGTH ANTACID • Fast-Acting Heartburn Relief • Helps Keep Acid Down for Hours ORIGINAL FLAVOR 100 Chewable Tablets IMPORTANT: Do not use if foil inner seal printed "SEALED for YOUR PROTECTION" is disturbed or missing. GAVISCON® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies and TORSO device is a registered trademark of the GlaxoSmithKline group of companies. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Twp, PA 15108 Made in France ©2012 GlaxoSmithKline 102597XA Gavison Extra Strength 100 count label
Principal Display Panel NDC 0135-0430-03 Gaviscon ® EXTRA STRENGTH ANTACID • Fast-Acting Heartburn Relief • Helps Keep Acid Down for Hours CHERRY FLAVOR 100 Chewable Tablets IMPORTANT: Do not use if foil inner seal printed "SEALED for YOUR PROTECTION" is disturbed or missing. GAVISCON® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies and TORSO device is a registered trademark of the GlaxoSmithKline group of companies. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Twp, PA 15108 Made in France ©2012 GlaxoSmithKline 102599XA Gavison Extra Strength Cherry 100 count label
Principal Display Panel NDC 0135-0096-26 Gaviscon ® REGULAR STRENGTH Alumina & Magnesium Trisilicate Tablets/ANTACID • Relieves Heartburn Caused by Acid Reflux • Unique Antacid Barrier ORIGINAL FLAVOR 100 Chewable Tablets IMPORTANT: Do not use if foil inner seal printed "SEALED for YOUR PROTECTION" is disturbed or missing. GAVISCON® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies and TORSO device is a registered trademark of the GlaxoSmithKline group of companies. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Twp, PA 15108 Made in France ©2012 GlaxoSmithKline 102598XA Gavison Regular Strength 100 count label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information (Extra Strength) • Each tablet contains: magnesium 35mg, sodium 20mg • Store at up to 25°C (77°F) in a dry place
Other information (Regular Strength) • Each tablet contains: magnesium 5mg, sodium 21 mg • Store at up to 25°C (77°F) in a dry place
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have • kidney disease • a sodium restricted diet
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are • taking a prescription drug. Antacids may interact with certain prescription drugs. • if you are on a sodium-restricted diet
Ask a doctor or pharmacist if you • are taking a prescription drug. Antacids may interact with certain prescription drugs.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • for peptic ulcers • if you have trouble swallowing
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call toll-free 1-888-367-6471 (English/Spanish) weekdays
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if • heartburn or stomach pain continues • you need to take this product for more than 14 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • do not take more than 16 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings (Extra Strength) Ask a doctor or pharmacist before use if you are • taking a prescription drug. Antacids may interact with certain prescription drugs. • if you are on a sodium-restricted diet When using this product • do not take more than 16 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Warnings (Regular Strength) Do not use • for peptic ulcers • if you have trouble swallowing Ask a doctor before use if you have • kidney disease • a sodium restricted diet Ask a doctor or pharmacist if you • are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if • heartburn or stomach pain continues • you need to take this product for more than 14 days Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API