NDC 0135-0098 Gaviscon Extra Strength

NDC Product Code 0135-0098

NDC 0135-0098-26

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Gaviscon Extra Strength with NDC 0135-0098 is a product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Gaviscon Extra Strength is . The product's dosage form is and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: -

Product Type: 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.

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)

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
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: 12-31-2019 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: I 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 Extra 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.