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Broncomar Maximum

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg in 10mL, GUAIFENESIN 200mg in 10mL
Labeler: Gadal Laboratories Inc
NDC Code: 53113-216

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 10 ml)              Purpose

Dextromethorphan HBr 30 mg ................... Cough Suppressant

Guaifenesin 200 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

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

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

BRONCOMAR  MAXIMUM
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-216
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA WHOLE 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
HYDROXYMETHYL CELLULOSE 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:53113-216-061 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)

Revised: 06/2014
 
Gadal Laboratories Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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