Cough Relief

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2020-11-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:05:00

Label at a glance#

ProductCough Relief Nighttime
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and uses

temporarily relieves cold symptoms cough runny nose and sneezing

Dosage and administration

take only as recommended do not exceed 4 doses per 24 hours use dosage cup provided mL = milliliter age dose   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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cold symptoms

  • cough
  • runny nose and sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice NightTime Cough Relief
Quality Choice NightTime Cough Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-237-12ML - Milliliter63868-2378fe1878e-5831-48da-90f9-318138b9d45712022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-23763868-237-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c5570c33-b7da-4782-b870-a092fad4715d2780ecd5-eeaf-483e-8e85-0bb64b806ebc2020-11-30WarningsExact identifier
spl id: c5570c33-b7da-4782-b870-a092fad4715d
spl set id: 2780ecd5-eeaf-483e-8e85-0bb64b806ebc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.