NDC 0113-7469 Basic Care Stomach Relief

Bismuth Subsalicylate

NDC Product Code 0113-7469

NDC Code: 0113-7469

Proprietary Name: Basic Care Stomach Relief Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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: ROUND (C48348)
Size(s):
17 MM
Imprint(s):
L469
Score: 1
Flavor(s):
WINTERGREEN (C73424)

Code Structure
  • 0113 - L. Perrigo Company
    • 0113-7469 - Basic Care Stomach Relief

NDC 0113-7469-65

Package Description: 30 BLISTER PACK in 1 CARTON > 1 TABLET, CHEWABLE in 1 BLISTER PACK

NDC Product Information

Basic Care Stomach Relief with NDC 0113-7469 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Stomach Relief is bismuth subsalicylate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: L. Perrigo Company

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Basic Care Stomach Relief Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: part335 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-11-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

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.

Basic Care Stomach Relief Product Label Images

Basic Care 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

Active Ingredient (In Each Tablet)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

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

Warnings

  • 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

Do Not Use

  • If you have •an ulcer •a bleeding problem •bloody or black stool

Ask A Doctor Before Use If You Have

  • •fever •mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking any drug for •anticoagulation (thinning 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 worse •ringing in the ears or loss of hearing occurs •diarrhea 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 right away (1-800-222-1222).

Directions

  • •chew or dissolve in mouth •adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed •do not exceed 8 doses (16 tablets) 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 tablet contains: calcium 190 mg •salicylate 104 mg •very low sodium •store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).

Inactive Ingredients

Calcium carbonate, D&C red #27 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium, stearic acid

Questions?

1-800-719-9260

* Please review the disclaimer below.

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