NDC 53113-215 Broncomar

NDC Product Code 53113-215

NDC CODE: 53113-215

Proprietary Name: Broncomar 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.

NDC Code Structure

  • 53113 - Gadal Laboratories Inc

NDC 53113-215-06

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 with NDC 53113-215 is a product labeled by Gadal Laboratories Inc. The product's dosage form is and is administered via form.

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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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 - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Broncomar Product Label Images

Broncomar 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 10 ml)              PurposeAcetaminophen 200 mg ............................. AnalgesicDextromethorphan HBr 13.33 mg ................... Cough SuppressantGuaifenesin 200 mg ................................... ExpectorantPhenylephrine HCl 5 mg ............................. Decongestant

Otc - Purpose

PurposeAnalgesicCough SuppressantExpectorantDecongestant

Indications & Usage

  • UsesFor temporary relief of bronchial and nasal congestionHelp loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.Teporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold


  • WarningsDo not exceed recommended dosage Liver warning: This product contains Acetaminophen. Sever liver damage may occur ifAdult takes more than 6 doses in 24 hours, which is the maximum daily amountChild takes more than 5 doses in 24 hoursTaken with other drugs containing AcetaminophenAdult has 3 or more alcoholic drinks everyday while using this productDo not give to children under 3 years of age or use for more than 10 days unless directed by a physician

Otc - Do Not Use

  • Do not useIf you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this productif you have a chronic pulmonary disease or shortness of breath unless directed by a doctoravoid alcoholic beverages while you are taking this productdo not use with any other drug containing Acetaminophen (prescirption or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a doctor or a pharmacist.Ask 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 emphysemaheart disease, high blood pressure, thyroid disease, or difficulty in urination due to the enlargement of prostate gland.The user has liver diseaseThe user is taking the blood thinning drug Warfarin.

Otc - Stop Use

  • Stop use and ask the doctor ifNervoisness, 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 periodAge                                                                        DoseAdults and children 12 years and over           10 mL (2 tsps) every 6 hoursChildren 6 to under 12 years of age.               5 mL (1 tsps) every 6 hoursChildren under 6 years of age                       Do not use

Inactive Ingredient

Inactive ingredientsAloe vera, citric acid, disodium EDTA, FD&C Red #40, hydroxyethyl cellulose, natural strawberry flavor, propylene glycol, water, sodium benzoate, sorbitol 70%, sucralose

* Please review the disclaimer below.