NDC 68016-679 Premier Value Multi Symptom Antacid Berry Flavor

Calcium Carbonate ,magnesium Hydroxide,simethicone

NDC Product Code 68016-679

NDC Code: 68016-679

Proprietary Name: Premier Value Multi Symptom Antacid Berry Flavor Additional informationCallout TooltipWhat 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: Calcium Carbonate ,magnesium Hydroxide,simethicone Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
WHITE (C48325 - PINKISH)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
R7
Score: 1
Flavor(s):
BERRY (C73365)

Code Structure
  • 68016 - Pharmacy Value Alliance Llc
    • 68016-679 - Premier Value Multi Symptom Antacid

NDC 68016-679-00

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Premier Value Multi Symptom Antacid Berry Flavor with NDC 68016-679 is a a human over the counter drug product labeled by Pharmacy Value Alliance Llc. The generic name of Premier Value Multi Symptom Antacid Berry Flavor is calcium carbonate ,magnesium hydroxide,simethicone. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Pharmacy Value Alliance 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 Additional informationCallout TooltipWhat 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.


Premier Value Multi Symptom Antacid Berry Flavor Active Ingredient(s)

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

  • CALCIUM CARBONATE 675 mg/1
  • MAGNESIUM HYDROXIDE 135 mg/1
  • DIMETHICONE 60 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmacy Value Alliance Llc
Labeler Code: 68016
FDA Application Number: part331 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-20-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Premier Value Multi Symptom Antacid Berry Flavor Product Label Images

Premier Value Multi Symptom Antacid Berry Flavor 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

Other

Drug Facts

Active Ingredients (In Each Tablet)

Calcium Carbonate USP 675 mgMagnesium hydroxide USP 135 mgSimethicone USP 60mg

Purpose

AntacidAntacidAntigas

Uses

  • Relieves: •heartburn •acid indigestion •pressure, bloating and discomfort commonly referred to as gas

Ask A Doctor Or Pharmacist Before Use If You Are

Now taking a prescription drug. Antacids may interact with certain prescription drugs.

When Using This Product

  • •Do not take more than 8 tablets in a 24-hour period, •Do not use the maximum dosage for more than 2 weeks

Directions

  • •chew 2 to 4 tablets as symptoms occur or as directed by a doctor.

Other Information

  • •each tablet contains: calcium 270 mg, magnesium 55 mg •store at room temperature •Avoid high humidity.

Inactive Ingredients

Corn starch, D&C Red No. 27, dextrose, FD&C Blue No. 1, flavor, magnesium stearate, maltodextrin, silicon dioxide, sucralose.

Questions?

1-866-467-2748

* Please review the disclaimer below.

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