NDC 67091-375 Childrens Chest Congestion Relief

Guaifenesin

NDC Product Code 67091-375

NDC CODE: 67091-375

Proprietary Name: Childrens Chest Congestion 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: Guaifenesin 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product (sustained-release) is not recommended for use in children younger than 12 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

NDC Code Structure

  • 67091 - Winco Foods, Llc
    • 67091-375 - Childrens Chest Congestion Relief

NDC 67091-375-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Childrens Chest Congestion Relief with NDC 67091-375 is a a human over the counter drug product labeled by Winco Foods, Llc. The generic name of Childrens Chest Congestion Relief is guaifenesin. The product's dosage form is solution and is administered via oral form.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Childrens Chest Congestion 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.


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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MALTITOL (UNII: D65DG142WK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • 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: Winco Foods, Llc
Labeler Code: 67091
FDA Application Number: part341 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: 09-18-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Childrens Chest Congestion Relief Product Label Images

Childrens Chest Congestion 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

Otc - Active Ingredient

Active ingredient(in each 5mL teaspoonful)Guaifenesin, USP 100 mg

Otc - Purpose

PurposeExpectorant

Indications & Usage

Uses■ Helps loosen phlegm (mucus) and thinbronchial secretions to rid the bronchialpassageways of bothersome mucus and makecoughs more productive

Warnings

WarningsAsk a doctor before use if the child has:■ cough that occurs with too much phlegm (mucus)■ persistent or chronic cough as occurs with  asthma.Stop use and ask a doctor if ■ cough lasts morethan 7 days, comes back, or occurs with fever,rash, or persistent headache. These could be signsof a serious illniess.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children  In case ofoverdose, get medical help or contact a PoisonControl Center right away.

Dosage & Administration

Directions■ do not take more than 6 doses in any 24-hour periodage                                                     dose                                                Children 6 yearsto under 12 years1-2 teaspoonfulsevery 4 hours.Children 4 yearsto under 6 years1/2-1 teaspoonfulevery 4 hours Children under4 years               do not use

Other Safety Information

Other information■ each 5 mL contains: sodium 3 mg■ store between 20-25ºC (68-77ºF)■do not refrigerate■ dosing cup provided■ Keep carton for full directions for use

Inactive Ingredient

Inactive ingredientsAnhydrous citric acid, dextrose, FD&C Blue # 1,FD&C Red # 40, flavor, glycerin, maltltol, propyleneglycol, purified water, saccharin sodium, sodiumbenzoate, sucralose, xanthan gum

Otc - Questions

Questions? Call 1-800-824-1706Monday - Friday 9am - 4pm MST

Package Labeling

WinCo®FOODSChestCongestionReliefChildren's**Compare to the active ingredient inChildren's MUCINEX® Chest CongestionGUAIFENESIN ORAL SOLUTION100 mg per 5 mL/EXPECTORANTAlcohol FreeThins & Loosens MucusFor Ages 4-12 YearsGrape Flavor4 FL OZ (118 mL)DISTRIBUTED BY: WINCO FOODS,LLC, BOISE, ID 83704** This product is not manufactured or distributed byRECKITT BENCKISER INC., distributor ofChildren's MUClNEX​® Chest Congestion.Comments & Questions?800-824-1706 · www.wincofoods.comDO NOT USE IF PRINTED SEALUNDER CAP IS TORN OR MISSINGCarton LabelBottle Labelres

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