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Broncomar EXPECTORANT

Medically reviewed on January 1, 2018

Dosage form: liquid
Ingredients: ACETAMINOPHEN 250mg in 10mL, DEXTROMETHORPHAN HYDROBROMIDE 13.33mg in 10mL, GUAIFENESIN 200mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 10mL
Labeler: Dannso Corp./d.b.a. Essential Products
NDC Code: 70242-102

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.

Broncomar Expectorant

Active Ingredients:(in each 10 ml.)Purpose

Acetaminophen 250 mg ........................................................

Analgesic

Dextromethorphan Hydrobromide 13.33 mg .......................

Cough Suppressant

Guaifenesin USP 200 mg......................................................

Expectorant

Phenylephrine HCl 5 mg.......................................................

Decongestant

Uses:

  • For temporary relief og Bronchial and Nasal congestion
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

Warnings

Do not exceed recommended dosage


Liver Warning this product contatins Acetaminophen. Severe liver damage may occur if


  • Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing Acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product
  • Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
  • 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 MAOI drug.
  • If you do not know if your prescription drug contains MAOI as 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 beverage while taking this product.
  • Do not use with any other drug containing Acetaminophen (prescription no nonprescription) If you are not sure whether a drug contains Acetaminophen, ask a doctor or pharmacist

Stop use and ask a doctor
  • Nervousness, dizziness or sleeplessness occurs.
  • Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.

Ask doctor before use if you have

  • Cough that occurs with too much phlegm(mucus)
  • Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • Heart disease, high blood pressure, thyroid disease, or difficulty in urination due enlargement of prostate gland.
  • The user has Liver diseases
  • The user us taking the blood thinning drug Warfarin

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 exceed 6 doses in any 24-hour period.

AGE
DOSE
Adults and Children 12 years and over
10 ml (2 tsps) every 6 hours
Children 6 to under 12 years of age
5 ml (1 tsp) every 6 hours
Children under 6 years of age
Do not  use



Other Information:

  • Each 10 mls contains: sodium 4 mg
  • Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
  • Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

Inactive Ingredient

Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Propylene Glycol USP, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

Questions or Comments

Call Weekdays from 9:30 AM to 5PM EST at Tel 305-261-762

Distributed by

Essential Products Miami FL 33126

www.jjjdistributors.com

Made in U.S.A.

BRONCOMAR  EXPECTORANT
acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE13.33 mg  in 10 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C RED NO. 40 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:70242-102-061 BOTTLE in 1 CARTON
1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2001
Labeler - Dannso Corp./d.b.a. Essential Products (059741071)
Registrant - Dannso Corp./d.b.a. Essential Products (059741071)
Establishment
NameAddressID/FEIOperations
Dannso Corp./d.b.a. Essential Products059741071LABEL(70242-102)
Establishment
NameAddressID/FEIOperations
GADAL Laboratories, Inc841305639MANUFACTURE(70242-102)

 
Dannso Corp./d.b.a. Essential Products

Further information

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

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