NDC 66715-6855 Stomach Lil Drug Store Products
Bismuth Subsalicylate Liquid Oral

Product Information

Product Code66715-6855
Proprietary Name 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.
Stomach Lil Drug Store Products
Non-Proprietary Name 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.
Bismuth Subsalicylate
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Lil' Drug Store Products, Inc
Labeler Code66715
FDA Application Number 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.
part335
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-01-2014
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 66715-6855-4

Package Description: 237 mL in 1 BOTTLE, PLASTIC

Product Details

Stomach Lil Drug Store Products is a human over the counter drug product labeled by Lil' Drug Store Products, Inc. The generic name of Stomach Lil Drug Store Products is bismuth subsalicylate. The product's dosage form is liquid and is administered via oral form.


What are Stomach Lil Drug Store Products Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SODIUM SALICYLATE (UNII: WIQ1H85SYP)
  • SORBIC ACID (UNII: X045WJ989B)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Patient Education

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.

Stomach Lil Drug Store Products Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts


Active Ingredient (In Each 30 Ml)



Bismuth subsalicylate 525 mg


Purpose



Upset stomach reliever/Antidiarrheal


Uses



relieves

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

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

Otc - Do Not Use



Do not use if you have

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

Otc - Ask Doctor



Ask a doctor before use if you have

  • fever
  • mucus in the stool

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking any drug for

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

Otc - When Using



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

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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



  • mL = milliliter
  • shake well before using
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • adults and children 12 years and over:
  • 30 mL (1 dose) every ½ to 1 hour as needed
  • do not exceed 8 doses (240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information



  • each 30 mL contains: sodium 10 mg
  • each 30 mL contains: salicylate 243 mg
  • sugar free
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients



benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid


Questions Or Comments?



Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)


Principal Display Panel - 237 Ml Bottle Label



QUALITY
GUARANTEED

Compare to the Active
Ingredient in Pepto-Bismol®*

Stomach

Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/Antidiarrheal

Relieves
• Diarrhea • Upset Stomach
• Heartburn • Indigestion • Nausea

8 FL OZ
(237 mL)

Lil'
Drug Store®


* Please review the disclaimer below.