Daytime Severe Cold and Flu

Manufacturer
Chain Drug Marketing Association, Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:16

Label at a glance#

ProductDaytime Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

•  temporarily relieves common cold/flu symptoms:    •  nasal congestion   •  sinus congestion & pressure    •  cough due to minor throat & bronchial irritation     •  minor aches & pains   •  headache   •  fever    •  sore throat •  reduces swelling of nasal passages •  temporarily restores freer breathing through the nose •  promotes nasal and/or sinus drainage •  helps loosen phlegm (mucus) and thin bronchial s...

Dosage and administration

•  take only as directed •  do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hours  children 4 to under 12 yrs ask a doctor  children under 4 yrs do not use

Storage and handling

•  store at 20-25°C (68-77ºF)   •  protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

•  temporarily relieves common cold/flu symptoms:
   •  nasal congestion   •  sinus congestion & pressure
   •  cough due to minor throat & bronchial irritation 
   •  minor aches & pains   •  headache   •  fever
   •  sore throat
•  reduces swelling of nasal passages
•  temporarily restores freer breathing through the nose
•  promotes nasal and/or sinus drainage
•  helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make some coughs more productive

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
•  more than 8 softgels in 24 hours, which is the maximum daily amount for this product 
•  with other drugs containing acetaminophen
•  3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
•  skin reddening    •  blisters    •  rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
•  with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•  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
•  liver disease    •  heart disease    •  high blood pressure
•  thyroid disease    •  diabetes
•  trouble urinating due to enlarged prostate gland
•  cough that occurs with too much phlegm (mucus)
•  persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if
•  you get nervous, dizzy or sleepless
•  pain, nasal congestion, or cough gets worse or lasts more than 7 days
•  fever gets worse or lasts more than 3 days
•  redness or swelling is present
•  new symptoms occur
•  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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

•  take only as directed
•  do not exceed 8 softgels per 24 hrs

adults & children

12 yrs & over

2 softgels with water

every 4 hours 

children 4 to under

12 yrs

ask a doctor 
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

•  store at 20-25°C (68-77ºF)   •  protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call toll free: 1-888-423-0139

SPL UNCLASSIFIED SECTION

Compare to the active ingredients in Vicks® DayQuil™ Severe Cold & Flu Relief LiquiCaps™*

Temporarily relieves common cold/flu symptoms:
aches, fever and sore throat
controls cough
nasal and chest congestion
thins and loosens mucus

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Procter & Gamble Company, owner of the registered trademarks Vicks®, DayQuil™.

100% QC SATISFACTION GUARANTEED

Distributed by CDMA, Inc.
43157 W Nine Mile
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Product of India
Packaged and Quality Assured in the USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label-467Label-467

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-467-242026-01-29C16284748780-149896155-a747-586f-e063-e6dba90add90QC ® QUALITY CHOICE Severe DayTime Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-467-24Daytime Severe Cold and Flu2 in 1 CARTONCAPSULE, LIQUID FILLED22
63868-467-24Daytime Severe Cold and Flu12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-467DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Legacy NDC, 2 package rows20250101_ed84f1a9-2b7c-4d55-884d-be13c58872db.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-467-24EA - Each63868-46765adae47-2edb-4e56-b621-8baf6f4c244112022-12-07

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-46763868-467-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
85ca8ac3-707f-4b86-8c90-0def61091048ed84f1a9-2b7c-4d55-884d-be13c58872db2024-12-16WarningsExact identifier
spl id: 85ca8ac3-707f-4b86-8c90-0def61091048
spl set id: ed84f1a9-2b7c-4d55-884d-be13c58872db

Reported adverse events (FAERS/openFDA)#

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