NDC 53113-218 Broncomar SF

NDC Product Code 53113-218

NDC 53113-218-06

Package Description: 1 BOTTLE in 1 CARTON > 177 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Broncomar SF with NDC 53113-218 is a product labeled by Gadal Laboratories Inc. The generic name of Broncomar SF is . The product's dosage form is and is administered via form.

Labeler Name: Gadal Laboratories Inc

Dosage Form: -

Product Type: 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.

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.

  • CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
  • EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)
  • GINKGO BILOBA WHOLE (UNII: 660486U6OI)
  • GOLDENSEAL (UNII: ZW3Z11D0JV)
  • HOREHOUND (UNII: K08036XEJV)
  • LICORICE (UNII: 61ZBX54883)
  • MENTHOL (UNII: L7T10EIP3A)
  • MULLEIN LEAF (UNII: 9936O846LI)
  • MYRRH (UNII: JC71GJ1F3L)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • GLYCERIN (UNII: PDC6A3C0OX)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Gadal Laboratories Inc
Labeler Code: 53113
Start Marketing Date: 06-01-2014 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: 12-31-2017 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: I 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

Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)

Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]

* Please review the disclaimer below.

Broncomar SF Product Label Images

Broncomar SF 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

Otc - Active Ingredient

Acvtive ingredients: (in each 5ml)              PurposeGuaifenesin 100 mg ................................... Expectorant

Otc - Purpose

PurposeExpectorant

Indications & Usage

  • UsesHelp loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.

Warnings

WarningsDo not exceed recommended dosage

Otc - Do Not Use

  • Do not useif you have a chronic pulmonary disease or shortness of breath unless directed by a doctorAsk the doctor before use if you havecough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Stop Use

  • Stop use and ask the doctor if Nervoisness, dizziness or sleeplessness occurs.Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsDo not take more than 6 doses in any 24-hour periodShake well before useAge                                                                        DoseAdults and children 12 years and over           10 mL (2 tsps) every 4 hoursChildren 6 to under 12 years of age.               5 mL (1 tsps) every 4 hoursChildren under 6 years of age                       Do not use

Inactive Ingredient

Inactive ingredientsBlue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, glycerin, gold seal root, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.

* Please review the disclaimer below.