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Cough Relief by QUALITY CHOICE (Chain Drug Marketing Association)

Medically reviewed on Oct 26, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 5mL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-069

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.

Drug Facts

Active ingredient (in each 5 mL, 1 teaspoon)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

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 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.

Ask a doctor before use if you have
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma 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 that lasts. These could be signs of a serious condition.

When using this product

do not use more than directed.

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions
  • take recommended dosage or as directed by a doctor
  • keep dosing cup with product
  • tsp = teaspoon, mL = milliliter
age dose 
 adults and children 12 years and over 2 tsp (10 mL) every 6-8 hrs, not to exceed 4 doses in 24 hours 
 children 6 to under 11 years 1 tsp (5 mL) every 6-8 hrs, not to exceed 4 doses in 24 hours
 children 4 to 5 years do not use unless directed by a doctor
 children under 4 years do not use

Other information
  • each 5 mL contains: sodium 6 mg
  • store at 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

artificial flavor, citric acid, disodium EDTA, FD&C yellow #6, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol 3350, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum

Principal Display Panel

Cough Relief

Cough Suppressant

Dextromehtorphan HBr

Cough Suppressant

For Ages 6 & Over

Alcohol Free

Orange Flavor

FL OZ (mL)

See side panel for full dosing directions.

Contains

No Fever Reducer

Or Pain Reliever

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON THE BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300 

Package Label

 

Quality Choice Cough Relief

COUGH RELIEF 
dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-069
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOL 3350 
PROPYLENE GLYCOL 
WATER 
D&C RED NO. 33 
SODIUM BENZOATE 
SUCRALOSE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-069-041 BOTTLE, PLASTIC in 1 BOX
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2014
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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Further information

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

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