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| Product NDC Code | 0135-0095 | ||||
|---|---|---|---|---|---|
| Drug Name | Gaviscon |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 245001, 252203, 404472, 1251365 |
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| Application Number | M001 | ||||
| Labeler Name | Haleon US Holdings 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 15 mL tablespoonful) Regular Strength Aluminum hydroxide 95 mg Magnesium carbonate 358 mg
Active ingredients (in each 5 mL teaspoonful) Extra Strength Aluminum hydroxide 254 mg Magnesium carbonate 237.5 mg
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 (Regular Strength) shake well take 1-2 tablespoonfuls four times a day or as directed by a doctor take after meals and at bedtime dispense product only by spoon or other measuring device
Directions (Extra Strength) shake well take 2-4 teaspoonfuls four times a day or as directed by a doctor take after meals and at bedtime dispense product only by spoon or other measuring device
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (Regular Strength) benzyl alcohol, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, saccharin sodium, sodium alginate, sorbitol solution, water, xanthan gum
Inactive ingredients (Extra Strength Cool Mint) benzyl alcohol, edetate disodium, flavor, glycerin, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, water, xanthan gum
Inactive Ingredients (Extra Strength Cherry) Benzyl alcohol, edetate disodium, flavor, glycerin, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, water, xanthan gum
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 relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Purpose Antacid
Spl product data elements
Usually a list of ingredients in a drug product.GAVISCON aluminum hydroxide and magnesium carbonate BENZYL ALCOHOL D&C YELLOW NO. 10 EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN SACCHARIN SODIUM SODIUM ALGINATE SORBITOL WATER XANTHAN GUM ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM CARBONATE CARBONATE ION cool mint GAVISCON aluminum hydroxide and magnesium carbonate BENZYL ALCOHOL EDETATE DISODIUM GLYCERIN SACCHARIN SODIUM DIMETHICONE SILICON DIOXIDE SODIUM ALGINATE SORBITOL WATER XANTHAN GUM ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM CARBONATE CARBONATE ION cool mint GAVISCON aluminum hydroxide and magnesium carbonate BENZYL ALCOHOL EDETATE DISODIUM GLYCERIN SACCHARIN SODIUM DIMETHICONE SILICON DIOXIDE SODIUM ALGINATE SORBITOL WATER XANTHAN GUM ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM CARBONATE CARBONATE ION
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 0135-0094-41 Gaviscon LIQUID ANTACID REGULAR STRENGTH Fast-Acting Heartburn Relief Helps Keep Acid Down for Hours COOL MINT FLAVOR 12 FL OZ (355 mL) FRONT: 00067473 BACK: 00067474 00067473 Gaviscon Regular Strength 12 fl oz
Principal Display Panel NDC 0135-0095-41 Gaviscon LIQUID ANTACID EXTRA STRENGTH Fast-Acting Heartburn Relief Helps Keep Acid Down for Hours COOL MINT FLAVOR 12 FL OZ (355 mL) FRONT: 00067475 BACK: 00067476 00067475 Gaviscon Extra Strength 12 fl oz
Principal Display Panel NDC 0135-0574-01 Gaviscon ® EXTRA STRENGTH LIQUID ANTACID Fast-Acting Heartburn Relief Helps Keep Acid Down for Hours CHERRY FLAVOR 12 fl oz (355 ml) ©2014 GlaxoSmithKline FRONT: 103698XA BACK: 103699XA Gavison Extra Strength Cherry 12 fl oz (355mL) 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.Additional Information Do not use if printed inner safety seal under cap is broken or missing. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Made in Mexico Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor.
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 have kidney disease. are on a sodium-restricted diet or a magnesium-restricted diet. are taking a prescription drug. Antacids may interact with certain prescription drugs.
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.
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? 1-888-367-6471
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 (Regular Strength) do not take more than 8 tablespoonfuls in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor laxative effect may occur
When using this product (Extra Strength) do not take more than 16 teaspoonfuls in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor laxative effect may occur
Storage and handling
Information about safe storage and handling of the drug product.Other information (Regular Strength) each tablespoon (15 mL) contains: magnesium 115 mg, sodium 52 mg store at up to 25°C (77°F). Avoid freezing. keep tightly closed
Other information (Extra Strength) each teaspoon (5 mL) contains: magnesium 80 mg, sodium 14 mg store at up to 25°C (77°F). Avoid freezing. keep tightly closed
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 Ask a doctor or pharmacist before use if you have kidney disease. are on a sodium-restricted diet or a magnesium-restricted diet. are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product (Regular Strength) do not take more than 8 tablespoonfuls in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor laxative effect may occur When using this product (Extra Strength) do not take more than 16 teaspoonfuls in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor laxative effect may occur Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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