NDC 73408-407 Thompson Chewable Bismuth Tabs

Bismuth Subsalicylate

NDC Product Code 73408-407

NDC CODE: 73408-407

Proprietary Name: Thompson Chewable Bismuth Tabs 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat occasional upset stomach, heartburn, and nausea. It is also used to treat diarrhea and help prevent travelers' diarrhea. It works by helping to slow the growth of bacteria that might be causing the diarrhea. This product should not be used to self-treat diarrhea if you also have a fever or blood/mucus in the stools. These could be signs of a serious health condition. Consult your doctor promptly for proper evaluation and treatment if you have these symptoms. This medication is used under a doctor's direction with other medication to treat stomach ulcers caused by a certain bacteria (Helicobacter pylori). Do not use this medication to self-treat ulcers. Bismuth subsalicylate is a salicylate. Salicylates can cause serious bleeding problems when used alone in patients with ulcers. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Product Characteristics

Color(s):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
RH;046
Score: 1

NDC Code Structure

  • 73408 - Thompson Safety Llc

NDC 73408-407-20

Package Description: 6 CELLO PACK in 1 BOX > 6 TABLET, CHEWABLE in 1 CELLO PACK

NDC Product Information

Thompson Chewable Bismuth Tabs with NDC 73408-407 is a a human over the counter drug product labeled by Thompson Safety Llc. The generic name of Thompson Chewable Bismuth Tabs is bismuth subsalicylate. The product's dosage form is tablet, chewable and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 308761.

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.

Thompson Chewable Bismuth Tabs 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.


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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DEXTRATES (UNII: G263MI44RU)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • ACACIA (UNII: 5C5403N26O)
  • ASPARTAME (UNII: Z0H242BBR1)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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: Thompson Safety Llc
Labeler Code: 73408
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: 08-11-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Thompson Chewable Bismuth Tabs Product Label Images

Thompson Chewable Bismuth Tabs 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

Otc - Active Ingredient

Active ingredient Bismuth Subsalicylate 262 mg

(each tablet contains 102 mg salicylate)

Otc - Purpose

PurposeUpset stomach reliever/antidiarrheal

Indications & Usage

  • Usesrelievestraveler's diarrheadiarrheaupset stomach due to overindulgence in food and drink, including: • heartburn, • indigestion, • nausea, • gas, • belching, • fullness

Warnings

  • WarningsReye'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

Otc - Do Not Use

  • Do not use if you havebloody or black stoolan ulcera bleeding problem

Otc - Ask Doctor

  • Ask a doctor before use if you havefevermucus in the stool

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist if you are taking any drug for
  • Anticoagulation (thinning of the blood)diabetesgoutarthritis

Otc - When Using

When using this product a temporary and harmless darkening of the tongue and/or stool may occur.

Otc - Stop Use

  • Stop use and ask a doctor ifsymptoms get worse or lasts more than 2 daysringing in the ears or loss of hearing occursdiarrhea lasts more than 2 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of accidental overdose, contact a physician or poison control center right away (1-800-222-1222)

Dosage & Administration

  • Directionschew or dissolve in mouthdrink plenty of clear fluids to help prevent dehydration caused by diarrheaAdults and children: (12 years and over) chew 2 tablets every 1/2 to 1 hour as neededdo not exceed 16 tablets in 24 hoursuse until diarrhea stops but not more than 2 daysChildren under 12 years: ask a doctor

Other Safety Information

  • Other informationphenylketonurics: contains phenylalanine 1.1mg per tablet
  • Calcium content per tablet: 73mg
  • Store at room temperature 59º-86ºF (15º-30ºC)tamper-evident sealed packetsdo not use any opened or torn packets

Inactive Ingredient

Inactive ingredientsacacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Otc - Questions

Questions or comments? 877.506.4291

* Please review the disclaimer below.