NDC 0322-2222 Percy Medicine

Bismuth Subsalicylate

NDC Product Code 0322-2222

NDC CODE: 0322-2222

Proprietary Name: Percy Medicine 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

NDC 0322-2222-00

Package Description: 1 BOTTLE in 1 BOX > 90 mL in 1 BOTTLE (0322-2222-03)

NDC 0322-2222-03

Package Description: 90 mL in 1 BOTTLE

NDC Product Information

Percy Medicine with NDC 0322-2222 is a a human over the counter drug product labeled by Merrick Medicine Company, Inc. The generic name of Percy Medicine is bismuth subsalicylate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Merrick Medicine Company, Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Percy Medicine 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 1050 mg/10mL

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.

  • WATER (UNII: 059QF0KO0R)
  • CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ACACIA (UNII: 5C5403N26O)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • POTASSIUM CARBONATE (UNII: BQN1B9B9HA)
  • RHUBARB (UNII: G280W4MW6E)
  • SUCROSE (UNII: C151H8M554)

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: Merrick Medicine Company, Inc
Labeler Code: 0322
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: 09-09-2019 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’.

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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...
[Read More]

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Percy Medicine Product Label Images

Percy Medicine 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

Drug Facts Active Ingredient

Active Ingredients           


Bismuth Subsalicylate

Purpose

Antidiarrheal

Warnings

Children and teenagers that have or are recovering from Chicken Pox, flu systems, or flue should NOT use this product.  If nausea, vomiting, or fever occur, consult a doctor because these symptoms could be an early sign of Reye Syndrome, a rare but serious condition.Allergy Alert: Contains Salicylates.  Do Not take if you are - allergic to salicylates (including aspirin) - taking other salicylate products.Do not use if you have - blood or black stool - an ulcer - bleeding problem. Ask a doctor before use if you are taking any drug for anti coagulation (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 consult a doctor if -  symptoms get worse - ringing in the ears or loss of hearing occurs - diarrhea lasts more that 2 days.if pregnant or breast feeding


ask a professional before use.  In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Inactive Ingredients

INACTIVE INGREDIENTS: CALCIUM HYDROXIDE, CITRIC ACID, ETHYL ALCOHOL, GLYCERINE, GUM ARABIC, OIL OF CINNAMON, OIL OF ORANGE, POTASSIUM CARBONATE, RHUBARB FLUID EXTRACT, SUGAR, PURIFIED WATER

Directions

(shake well before using)Adults and children 12 yrs and over : 2 teaspoonfuls every hour as needed , not to exceed 4 doses in 24 hours and not more than 2 days.Children under 12: Consult a doctor.

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses:

Relieves diarrhea, reduces number of bowel movements.


Helps firm stool.Relieves nausea, heartburn, fullness due to overindulgence of food and drink.

Package Label

PERCY MEDICINE


FOR DIARRHEA


ALCOHOL 5%


90 ml/ 3 fl oz

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