NDC 46994-372 Digestive Relief Regular Strength

Bismuth Subsalicylate

NDC Product Code 46994-372

NDC 46994-372-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Digestive Relief Regular Strength with NDC 46994-372 is a a human over the counter drug product labeled by Being Well. The generic name of Digestive Relief Regular Strength is bismuth subsalicylate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Being Well

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.

Digestive Relief Regular Strength 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)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SODIUM SALICYLATE (UNII: WIQ1H85SYP)
  • SORBIC ACID (UNII: X045WJ989B)
  • METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)

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: Being Well
Labeler Code: 46994
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: 08-30-2019 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.

Digestive Relief Regular Strength Product Label Images

Digestive Relief Regular Strength 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/Antidiarrheal

Uses

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

Warnings

  • Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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 havean ulcera bleeding problembloody 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 fordiabetesgoutarthritisanticoagulation (thinning the blood)

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

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Childen.

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

Directions

  • ML = millilitershake well before usingmeasure only with dosing cup provided. do not use any other dosng devicekeep dosing cup with productadults and children 12 years and over:30 mL (1 dose) every 1/2 to 1 hour as neededdo not exceed 8 doses (240 mL) in 24 hoursuse until diarrhea stops but not more than 2 dayschildren under 12 years of age: ask a doctordrink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information

  • Each 30 mL contains: sodium 6 mgeach 30 mL contains: salicylate 243 mglow sodiumkeep tightly closedprotect from freezingavoid excessive heat (over 104ºF or 40ºC)

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

Package Label

BEING WELL Digestive Relief

* Please review the disclaimer below.