NDC 0135-0095 Gaviscon

Aluminum Hydroxide And Magnesium Carbonate

NDC Product Code 0135-0095

NDC 0135-0095-41

Package Description: 355 mL in 1 BOTTLE

NDC Product Information

Gaviscon with NDC 0135-0095 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Gaviscon is aluminum hydroxide and magnesium carbonate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 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 254 mg/5mL
  • MAGNESIUM CARBONATE 237.5 mg/5mL

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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.
  • 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: part331 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-14-2011 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Gaviscon 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 Ingredient (In Each 15Ml Tablespoonful) Regular Strength

Aluminum hydroxide 95mgMagnesium carbonate 358mg

Active Ingredient (In Each 5Ml Teaspoonful) Extra Strength

Aluminum hydroxide 254mgMagnesium carbonate 237.5mg

Purpose

Antacid

Uses

  • Relieves •heartburn •acid indigestion •sour stomach •upset stomach associated with these symptoms

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 (Regular Strength)

  • •do not take more than 8 tablespoonfuls in 24 hours •do not use the maximum dosage for more than 2 weeks •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.

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

Other Information (Regular Strength)

  • •each tablespoon (15mL) contains: magnesium 115mg, sodium 52mg •store at up to 25°C (77°F); avoid freezing •keep tightly closed

Other Information (Extra Strength)

  • •each teaspoon (5mL) contains: magnesium 80mg, sodium 14mg •store at up to 25°C (77°F); avoid freezing •keep tightly closed

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, edentate disodium, flavor, glycerin, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, water, xanthan gum

* Please review the disclaimer below.