NDC 63868-305 Qc Stomach Relief Cherry Flavor

Bismuth Subsalicylate

NDC Product Code 63868-305

NDC 63868-305-08

Package Description: 236 mL in 1 BOTTLE

NDC Product Information

Qc Stomach Relief Cherry Flavor with NDC 63868-305 is a a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Qc Stomach Relief Cherry Flavor is bismuth subsalicylate. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Quality Choice (chain Drug Marketing Association)

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed 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.


Qc Stomach Relief Cherry Flavor 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.

  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • D&C RED NO. 22 (UNII: 1678RKX8RT)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • 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: Quality Choice (chain Drug Marketing Association)
Labeler Code: 63868
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: 04-15-2019 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.

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.

Qc Stomach Relief Cherry Flavor Product Label Images

Qc Stomach Relief Cherry Flavor 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 Dose Cup)

Bismuth subsalicylate 525 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

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 or 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 or last more than 2 days •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

  • •shake well before use •for accurate dosing, use dose cup •adults and children 12 years and over: 1 dose (30 mL) every 1/2 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: ask a doctor •drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information

  • •each 30 mL contains: sodium 10 mg •salicylate 261 mg •low sodium •sugar free •store at room temperature •protect from freezing •avoid excessive heat (more than 104°F 40°C)

Inactive Ingredients

Carboxymethylcellulose sodium, D&C Red # 22, D&C Red # 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

* Please review the disclaimer below.

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