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Breacold Adult

Dosage form: liquid
Ingredients: GUAIFENESIN 100mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL
Labeler: Menper Distributors, Inc.
NDC Code: 53145-040

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.

Active ingredients (in each 5mL tsp)

Guaifenesin 100 mg………………………………Expectorant

Dextromethorphan HBr 10 mg…………………….Cough suppressant

Expectorant

Cough Suppressant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold or inhaled irritants

Warnings  Do not exceed recommended dosage.

A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to reoccur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Do not use:

  • This product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Keep out of reach of children.

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

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • ´╗┐Do not exceed 6 doses in 24 hours.

age                                                                        dose

Adults and children                                                  2 teaspoonfuls (10 mL)

12 years of age and over....................................... every 4 hours

Children 6 to under                                                  1 teaspoonful (5 mL)

12 years of age..................................................... every 4 hours

Children 2 to under                                                  1/2 teaspoonful (2.5 mL)

6 years of age....................................................... every 4 hours 

Children under 2 years of age.................................. consult your doctor

Other information

  • Store this product between 15°-30°C (59°-86°F)

Inactive ingredients ´╗┐Citric acid, D&C red #33, glycerin, methylparaben, natural raspberry flavor, propylene glycol, propylparaben , purified water, sucrose

BREACOLD ADULT 
guaifenesin, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-040
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE 
GLYCERIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
D&C RED NO. 33 
SUCROSE 
WATER 
Packaging
#Item CodePackage Description
1NDC:53145-040-041 BOTTLE in 1 CARTON
1180 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/21/2012
Labeler - Menper Distributors, Inc. (101947166)

Revised: 08/2013
 
Menper Distributors, 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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