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Broncomar DM by Gadal Laboratories Inc

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Gadal Laboratories Inc
NDC Code: 53113-217

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Acvtive ingredients: (in each 5ml)              Purpose

Dextromethorphan HBr 10 mg ................... Cough Suppressant

Guaifenesin 100 mg ................................... Expectorant

Purpose

Cough Suppressant

Expectorant

Uses

  • Help 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

Warnings

Do not exceed recommended dosage

Do not use

  • If 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 product
  • if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
  • avoid alcoholic beverages while you are taking this product

Ask the doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

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

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.

Directions

  • Do not take more than 6 doses in any 24-hour period
  • Shake well before use

Age                                                                        Dose

Adults and children 12 years and over           10 mL (2 tsps) every 4 hours

Children 6 to under 12 years of age.               5 mL (1 tsps) every 4 hours

Children under 6 years of age                       Do not use

Inactive ingredients

Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, gold seal root, honey, 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.

BRONCOMAR  DM
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-217
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CAULOPHYLLUM THALICTROIDES ROOT 
ANHYDROUS CITRIC ACID 
ECHINACEA, UNSPECIFIED 
EUCALYPTUS CAMALDULENSIS LEAF OIL 
GINKGO BILOBA WHOLE 
GOLDENSEAL 
HONEY 
HOREHOUND 
LICORICE 
MENTHOL 
MULLEIN LEAF 
MYRRH 
POTASSIUM SORBATE 
ULMUS RUBRA BARK 
SODIUM BENZOATE 
PROPYLENE GLYCOL 
WATER 
SODIUM CHLORIDE 
SUCRALOSE 
PRUNUS SEROTINA BARK 
ZINC SULFATE 
Packaging
#Item CodePackage Description
1NDC:53113-217-061 BOTTLE in 1 CARTON
1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2014
Labeler - Gadal Laboratories Inc (841305639)

 
Gadal Laboratories Inc

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Medically reviewed on Jun 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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