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Cough Relief Nighttime by QUALITY CHOICE (Chain Drug Marketing Association)

Medically reviewed on April 23, 2018

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-237

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 ingredients (in each 30 mL)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purposes

Cough suppressant

Antihistamine

Uses

temporarily relieves cold symptoms

  • cough
  • runny nose and sneezing

Warnings

Do not use
  • to make a child sleepy
  • 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
  • a sodium-restricted diet
  • asthma
  • emphysema
  • glaucoma
  • chronic bronchitis
  • excessive phlegm (mucus)
  • breathing problems
  • persistent or chronic cough
  • cough associated with smoking
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain or cough gets worse or lasts more than 7 days
  • cough comes back or occurs with rash or headache that lasts

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 (1-800-222-1222) immediatly.

Directions
  • take only as recommended
  • do not exceed 4 doses per 24 hours
  • use dosage cup provided
  • mL = milliliter
agedose 
 adults & children 12 years and over 30 mL every 6 hours
 children 4 to 11 years do not use unless directed by a doctor
 children under 4 years do not use

  • When using DayTime and Nighttime products,carefully read each label to ensure correct dosing

Other information
  • each 30 mL contains; sodium 36 mg
  • store at room temperature

Inactive ingredients

alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

 Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredients in VICKS® NYQUIL® Cough

Nighttime Cough

Cough Relief 

Dextromethorphan HBr | Doxylamine Succinate

For Relief of:

cough | Runny Nose & Sneezing

For Ages 12 & Over

Alcohol 10 %

FL OZ (mL)

CHERRY FLAVOR

*This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks® NyQuil® Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

Failure to follow these warnings could result in serious consequences.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product Label

Quality Choice NightTime Cough Relief

COUGH RELIEF  NIGHTTIME
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-237
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
TRISODIUM CITRATE DIHYDRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-237-12355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/31/2016
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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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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