NDC 70000-0439 Leader Stomach Relief

Bismuth Subsalicylate

NDC Product Code 70000-0439

NDC 70000-0439-1

Package Description: 118 mL in 1 BOTTLE

NDC 70000-0439-2

Package Description: 236 mL in 1 BOTTLE

NDC Product Information

Leader Stomach Relief with NDC 70000-0439 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Stomach Relief is bismuth subsalicylate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Cardinal Health

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.

Leader 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 525 mg/30mL

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)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Cardinal Health
Labeler Code: 70000
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: 06-07-2019 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.

Leader Stomach Relief Product Label Images

Leader 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 30 Ml)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and anti-diarrheal

Use(S)

  • Relieves:diarrheaheartburnindigestionnauseaupset stomach associated with these symptoms

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 areallergic to salicylates (including aspirin)taking other salicylate products

Do Not Use If You Have

  • An ulcerbloody or black stoola 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 for anticoagulation (thinning of the blood)diabetesgoutarthritis

When Using This Product

A temporary, but harmless darkening of the stool and/or tongue may occur

Stop Use And Ask 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 usemL = milliliterTBSP = tablespoonadults 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 fluids to help prevent dehydration caused by diarrhea

Other Information

  • Each 30 mL or 2 TBSP contains:potassium 25 mgsalicylate 260 mgsodium 8 mgprotect from freezingavoid excessive heat (over 104oF or 40oC)dosage cup provided

Inactive Ingredients

Benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

* Please review the disclaimer below.