NDC 0135-0096 Gaviscon Regular Strength

Aluminum Hydroxide And Magnesium Trisilicate

NDC Product Code 0135-0096

NDC CODE: 0135-0096

Proprietary Name: Gaviscon Regular Strength What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aluminum Hydroxide And Magnesium Trisilicate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat the symptoms of too much stomach acid such as stomach upset, heartburn, and acid indigestion. Aluminum and magnesium antacids work quickly to lower the acid in the stomach. Liquid antacids usually work faster/better than tablets or capsules. This medication works only on existing acid in the stomach. It does not prevent acid production. It may be used alone or with other medications that lower acid production (including H2 blockers such as cimetidine/ranitidine and proton pump inhibitors such as omeprazole).

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
GAVISCON
Score: 1
Flavor(s):
VANILLA (C73421 - VANILLA MINT)
CHERRY (C73375)

NDC Code Structure

  • 0135 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0135-0096-26

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Gaviscon Regular Strength with NDC 0135-0096 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Gaviscon Regular Strength is aluminum hydroxide and magnesium trisilicate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Gaviscon Regular Strength Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALUMINUM HYDROXIDE 80 mg/1
  • MAGNESIUM TRISILICATE 14.2 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALGINIC ACID (UNII: 8C3Z4148WZ)
  • CALCIUM STEARATE (UNII: 776XM7047L)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SUCROSE (UNII: C151H8M554)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SORBITOL (UNII: 506T60A25R)
  • MANNITOL (UNII: 3OWL53L36A)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ALGINIC ACID (UNII: 8C3Z4148WZ)
  • CALCIUM STEARATE (UNII: 776XM7047L)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • MANNITOL (UNII: 3OWL53L36A)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCROSE (UNII: C151H8M554)
  • ALGINIC ACID (UNII: 8C3Z4148WZ)
  • CALCIUM STEARATE (UNII: 776XM7047L)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
FDA Application Number: NDA018685 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-13-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Gaviscon Regular Strength Product Labeling Information

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.

Product Labeling Index

Active Ingredients (In Each Tablet) (Extra Strength)

Aluminum hydroxide 160mgMagnesium carbonate 105mg

Active Ingredients (In Each Tablet) (Regular Strength)

Dried aluminum hydroxide gel 80mgMagnesium trisilicate 14.2mg

Purpose

AntacidAntacid

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

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.

In case of overdose, get medical help or contact a Poison Control Center.

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

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

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

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

* Please review the disclaimer below.