NDC 68016-124 Premier Value

Bismuth Subsalicylate

NDC Product Code 68016-124

NDC Code: 68016-124

Proprietary Name: Premier Value 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: Bismuth Subsalicylate 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):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
17 MM
Imprint(s):
RP124
Score: 1

NDC Code Structure

  • 68016 - Chain Drug Consortium,llc
    • 68016-124 - Premier Value

NDC 68016-124-30

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Premier Value with NDC 68016-124 is a a human over the counter drug product labeled by Chain Drug Consortium,llc. The generic name of Premier Value is bismuth subsalicylate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Chain Drug Consortium,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 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.

  • BISMUTH SUBSALICYLATE 262 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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • SORBITOL (UNII: 506T60A25R)
  • 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: Chain Drug Consortium,llc
Labeler Code: 68016
FDA Application Number: part335 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: 05-22-2019 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

Bismuth Subsalicylate

Bismuth Subsalicylate is pronounced as (biz muth) (sub sa lis' i late)

Why is bismuth subsalicylate medication prescribed?
Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of med...
[Read More]

* Please review the disclaimer below.

Premier Value 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 Tablet)

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal/ upset stomach reliever

Uses

  • Relieves:▪travelers’ diarrhea▪diarrhea▪upset stomach due to overindulgence in food and drink, including:▪heartburn▪indigestion▪nausea▪gas▪belching▪fullness

Warnings

  • Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy alert: Contains salicylate. Do not take if you are▪allergic to salicylates (including aspirin)▪taking other salicylate products

Do Not Use If You Have

  • ▪an ulcer▪a bleeding problem▪bloody or black stool

Ask A Doctor Before Use If You Have

  • ▪fever▪mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are Taking Any Drug For

  • ▪anticoagulation (thinning of the blood)▪diabetes▪gout▪arthritis

When Using This Product

A temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop Use And Ask A Doctor If

  • ▪symptoms get worse or last more than 2 days▪ringing in the ears or loss of hearing occurs▪diarrhea lasts more than 2 days

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Directions

  • ▪chew or dissolve tablets in mouth.▪adults and children 12 years and older: 2 tablets every 1/2 to 1 hour as needed▪do not exceed 8 doses (16 tablets) in 24 hours▪use until diarrhea stops but not more than 2 days▪children under 12 years: ask a doctor▪drink plenty clear fluids to help prevent dehydration caused by diarrhea.

Other Information

  • ▪each tablet contains: salicylate 102 mg▪store at room temperature.▪avoid excessive heat▪keep this carton for future reference on full labelingTAMPER EVIDENT: Do not use if printed inner wrap is broken or missing.

Inactive Ingredients

Flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, red# 27 aluminum lake, sorbitol, sucralose.

Principal Display

  • Premier Value®NDC# 68016-124-30COMPARE TO THE ACTIVE INGREDIENT PEPTO-BISMOL®PINK BISMUTHBismuth Subsalicylate 262 mgProvides soothing Relief for: •Upset stomach •Indigestion •Nausea •Heartburn •Diarrhea30 CHEWABLE TABLETSManufactured For Your Military ExchangesDistributed By:Chain Drug Consortium, LLC.3301 N.W. Boca Raton Blvd.,Suite 101, Boca Raton, FL 33431*This product is not manufactured or distributed by The Procter & Gamble Inc., owner of the registered trademark Pepto-Bismol®.If any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

* Please review the disclaimer below.

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