NDC 68210-0469 Stomach Relief

Bismuth Subsalicylate

NDC Product Code 68210-0469

NDC Code: 68210-0469

Proprietary Name: Stomach Relief 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.

Product Characteristics

Color(s):
PINK (C48328)
Shape: CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
854
Score: 1

NDC Code Structure

  • 68210 - Spirit Pharmaceuticals Llc
    • 68210-0469 - Stomach Relief

NDC 68210-0469-3

Package Description: 1 BOTTLE in 1 CARTON > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Stomach Relief with NDC 68210-0469 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Stomach Relief is bismuth subsalicylate. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Spirit Pharmaceuticals Llc

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended 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.

Stomach Relief 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/1

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)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • WATER (UNII: 059QF0KO0R)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Spirit Pharmaceuticals Llc
Labeler Code: 68210
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: 06-28-2019 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’.

* Please review the disclaimer below.

Stomach Relief Product Label Images

Stomach Relief 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

Aerosil, beeswax, FD&C Red#33. FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl


cellulose, sorbitol solution, titanium dioxide

Otc - Purpose

Active ingredient                                                                                Purpose(in each softgel)Bismuth subsalicylate 262 mg...............Upset stomach reliever and anti-diarrheal

Uses

  • Relievestravelers' diarrheadiarrheaupset stomach due to overindulgence in food and drink, including:
  • Heartburnindigestionnauseagasbelchingfullness

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 areallergic to salicylates (including aspirin)taking other salicylate products

Otc - Do Not Use

  • 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

Otc - Ask Doctor/Pharmacist

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

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 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Swallow with water, do not chewadults and children 12 years and over: 2 softgels (1 dose) every 1/2 hour or 4 softgels (2
  • Doses) every hour as needed for diarrhea
  • 2 softgels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 softgels) 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 softgel contains: salicylate 99 mg n very low sodiumstore between 15-30°C (59-86°F)

* Please review the disclaimer below.

Previous Code
68210-0402
Next Code
68210-0800