Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID fe5fd29e-7f81-4633-8c3b-010d68abe701
Route
ORAL
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Alcohol Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-07-31 Until 2027-03-31

Description

Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

Cough suppressant Antihistamine


Medication Information

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Uses
  • temporarily relieves cold symptoms
    • cough due to minor throat and bronchial irritation
    • runny nose and sneezing
Purposes

Cough suppressant

Antihistamine

Directions
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • take only as directed
  • mL = milliliter
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use
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.

Product Label
QUALITY CHOICE Nighttime Cough
Other Information
  • each 30 mL contains; sodium 29 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
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 | Cough Suppressant

Doxylamine Succinate | Antihistamine

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 The Proctor & Gamble Company.Vicks® NyQuil® are registered trademarks of The Procter & Gamble Company.

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

Distributed by C.D.M.A., Inc.©

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

When Using This Product
  • 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

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 (1-800-222-1222) immediatly.

Active Ingredients (in Each 30 Ml)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses
  • temporarily relieves cold symptoms
    • cough due to minor throat and bronchial irritation
    • runny nose and sneezing
Purposes

Cough suppressant

Antihistamine

Directions
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • take only as directed
  • mL = milliliter
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use
Do Not Use (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.

Product Label
QUALITY CHOICE Nighttime Cough
Other Information (Other information)
  • each 30 mL contains; sodium 29 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (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? (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 | Cough Suppressant

Doxylamine Succinate | Antihistamine

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 The Proctor & Gamble Company.Vicks® NyQuil® are registered trademarks of The Procter & Gamble Company.

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

Distributed by C.D.M.A., Inc.©

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

When Using This Product (When using this product)
  • 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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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