NDC 53217-060 Bismatrol

NDC Product Code 53217-060

NDC CODE: 53217-060

Proprietary Name: Bismatrol 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.

Product Characteristics

Color(s):
PINK (C48328)
Flavor(s):
WINTERGREEN (C73424)

NDC Code Structure

  • 53217 - Aidarex Pharmaceuticals Llc

NDC 53217-060-01

Package Description: 236 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Bismatrol with NDC 53217-060 is a product labeled by Aidarex Pharmaceuticals Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 308762.

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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • D&C RED NO. 22 (UNII: 1678RKX8RT)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Aidarex Pharmaceuticals Llc
Labeler Code: 53217
Start Marketing Date: 05-30-2008 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: 12-31-2018 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

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.

Bismatrol 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 Tbsp)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal

Uses

  • Relieves: diarrhea
  • Heartburn
  • Indigestion
  • Nausea
  • Upset stomach associated with these symptoms

Warnings

  • Reye's syndrome: Children and teenagers who have or are recovering from children 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 areallergic to salicylates (including aspirin)
  • Taking other salicylate products

Do Not Use If You Have

  • Bloody or black stoolan ulcera bleeding problem

Ask A Doctor Before Use If You Have

  • Fevermucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking any drug foranticoagulation (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 worseringing in the ears or loss of hearing occursdiarrhea lasts more than 2 days

If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison control center  immediately.

Directions

  • Shake well before usefor accurate dosing, use dose cupadults 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 hoursuse until diarrhea stops but not more than 2 dayschildren under 12 years: ask a doctordrink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information

  • Each Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mgprotect from freezingavoid excessive heat (over 104oF or 40oC)TAMPER EVIDENT:Do not use if imprinted shrinkband is missing or broken.

Inactive Ingredients

Benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880

Keep Out Of Reach Of Children Section

KEEP OUT OF REACH OF CHILDREN SECTION.

* Please review the disclaimer below.