NDC 0121-4803 Pink Bismuth

Bismuth Subsalicylate

NDC Product Code 0121-4803

NDC CODE: 0121-4803

Proprietary Name: Pink Bismuth 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.

NDC Code Structure

  • 0121 - Pharmaceutical Associates, Inc.

NDC 0121-4803-30

Package Description: 4 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Pink Bismuth with NDC 0121-4803 is a a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Pink Bismuth is bismuth subsalicylate. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Pharmaceutical Associates, Inc.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Pink Bismuth 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/15mL

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.

  • XANTHAN GUM (UNII: TTV12P4NEE)
  • DOCUSATE SODIUM/SODIUM BENZOATE (UNII: 656HXR6YXN)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • D&C RED NO. 22 (UNII: 1678RKX8RT)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • SACCHARIN (UNII: FST467XS7D)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM SALICYLATE (UNII: WIQ1H85SYP)

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.
  • 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: Pharmaceutical Associates, Inc.
Labeler Code: 0121
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: 09-20-2009 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: 12-31-2021 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’.

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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...
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Pink Bismuth 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 15 Ml Tablespoon)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

  • Relieves:heartburnindigestionupset stomachnauseadiarrhea(Also relieves traveler's diarrhea and gas, belching, and fullness due to overindulgence with food and drink.)

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 or 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 areallergic to salicylates (including aspirin)taking other salicylate products

Do Not Use If You Have

  • An ulcera bleeding problembloody or black stool

Ask A Doctor Before Use If You Have

  • Fevermucus in the stool

Stop Use And Ask A Doctor If

  • Symptoms get worseringing in the ears or loss of hearing occursdiarrhea lasts more than 2 days

Directions

  • Shake well before use.adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as neededdo not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours.use until diarrhea stops, but not more than 2 days.children under 12 years: ask a doctor.drink plenty of clear fluids to help prevent dehydration caused by diarrhea.

Other Information

  • Each Tbsp (15 mL) contains: sodium 5 mglow sodiumsugar freesalicylate 145 mgmay not meet USP requirements for pHpink colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-4803-30 (unit dose cups of 30 mL).store at 20° to 25°C (68° to 77°F). Protect from freezing.

Inactive Ingredients

D&C Red No. 22, D&C Red No. 28, methyl salicylate, peppermint flavor, potassium sorbate, purified water, salicylic acid, sodium benzoate, sodium saccharin, sodium salicylate, veegum and xanthan gum.

* Please review the disclaimer below.