NDC 68016-249 Premier Value Maximum Strength Assorted Fruit

Calcium Carbonate, Simethicone

NDC Product Code 68016-249

NDC Code: 68016-249

Proprietary Name: Premier Value Maximum Strength Assorted Fruit 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: Calcium Carbonate, Simethicone 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.

Product Characteristics

Color(s):
ORANGE (C48331)
YELLOW (C48330)
RED (C48326 - PINKISH)
Shape: ROUND (C48348)
Size(s):
17 MM
Imprint(s):
RP104
Score: 1
Flavor(s):
FRUIT (C73389 - ASSORTED)

NDC Code Structure

  • 68016 - Pharmacy Value Alliance, Llc
    • 68016-249 - Premier Value Maximum Strength

NDC 68016-249-00

Package Description: 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Premier Value Maximum Strength Assorted Fruit with NDC 68016-249 is a a human over the counter drug product labeled by Pharmacy Value Alliance, Llc. The generic name of Premier Value Maximum Strength Assorted Fruit is calcium carbonate, 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 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.

Premier Value Maximum Strength Assorted Fruit 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.

  • CALCIUM CARBONATE 1000 mg/1
  • DIMETHICONE 60 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.

  • ADIPIC ACID (UNII: 76A0JE0FKJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: Pharmacy Value Alliance, Llc
Labeler Code: 68016
FDA Application Number: part332 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: 04-22-2019 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: 12-31-2020 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.

Information for Patients

Calcium Carbonate

Calcium Carbonate is pronounced as (kal' see um) (kar' bon ate)

Why is calcium carbonate medication prescribed?
Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervo...
[Read More]
Simethicone

Simethicone is pronounced as (sye meth' i kone)
Why is simethicone medication prescribed?
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.This medication is sometimes prescribed for other uses;...
[Read More]

* Please review the disclaimer below.

Premier Value Maximum Strength Assorted Fruit Product Label Images

Premier Value Maximum Strength Assorted Fruit 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)

Calcium carbonate 1000 mgSimethicone 60 mg

Purpose

AntacidAntigas

Uses

  • Relieves:▪acid indigestion▪heartburn▪sour stomach▪upset stomach due to these symptoms▪bloating and pressure commonly referred to as gas

Warnings

Do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Ask A Doctor Before Use If You Have

  • ▪kidney stones▪a calcium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

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

When Using This Product

At maximum dose, constipation may occur.

Stop Use And Ask A Doctor If

Symptoms persist for more than 2 weeks.

Directions

  • ▪adults and children 12 years and older: chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole.▪do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Other Information

  • ▪each tablet contains: calcium 400 mg▪store at room temperature▪keep tightly closed and dry ▪avoid freezing▪do not use if printed inner seal is broken or missing

Inactive Ingredients

Adipic acid, D&C Yellow No. 10, dextrose, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, silica, starch, sucralose.

* Please review the disclaimer below.

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