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Family Care Cough and Cold

Medically reviewed on July 31, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 40mg in 10mL, GUAIFENESIN 400mg in 10mL
Labeler: United Exchange Corp.
NDC Code: 65923-633

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 10 mL)                                                               Purpose

Dextromethorphan HBr, USP 20 mg............................................Cough suppressant

Guaifenesin, USP 200 mg....................................................................Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain brnchial tubes.

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinson's disease), or until 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.

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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
  • measure only with dosing cup provided. Keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
 age dose
 adults and children 12 years and over 10 mL every 4 hours
 children under 12 years do not use

Other information

  • each 10 mL contains: sodium 3 mg
  • Store at 20° to 25°C (68° to 77°F). Do not refrigerate.

Inactive ingredients

citric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

FAMILY CARE COUGH AND COLD 
dextromethorphan hydrobromide, and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-633
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE40 mg  in 10 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
MENTHOL 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:65923-633-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/29/2015
Labeler - United Exchange Corp. (840130579)

 
United Exchange Corp.

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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