FDA.reportPublic FDA data

Cold and Flu

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2024-04-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:19

Label at a glance#

ProductCold and Flu Daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation

Dosage and administration

do not take more than directed (see overdose warning) do not take more than 4 doses in 24-hour period adults and children 12 years and over: take 2 softgels with water every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • fever
    • nasal congestion
    • cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen I 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

Allery 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

OTC - DO NOT USE SECTION

  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the user has

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • nervousness, dizziness, or sleeplessness occur
  • 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,

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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • do not take more than 4 doses in 24-hour period
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Other information

OTHER SAFETY INFORMATION

  • store between 15-30ºC (59-86º)
  • avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol white ink

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the Active Ingredients in VICKS® DAYQUIL® COLD & FLU LIQUICAPS®

Non-Drowsy

Day Time 

Multi-Symptom Relief For Cold/Flu

Acetaminophen,  Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever | Fever Reducer

Cough Suppressant | Nasal Decongestant

Non-Drowsy | Alcohol Free | Antihistamine Free

Softgels

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OR TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® DayQuil® and LiquiCaps® are registered trademarks of The Procter & Gamble Company.

Distributed by C.D.M.A., Inc©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITYCHOICE Non-Drowsy Day Time Cold and Flu Relief
QUALITYCHOICE Non-Drowsy Day Time Cold and Flu Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-736-24Cold and FluDaytime1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED13
63868-736-24Cold and FluDaytime24 in 1 CARTONCAPSULE, LIQUID FILLED243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-736COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Current NDC, Legacy NDC, 2 package rows20240423_fc7954a6-d061-4160-b1d1-a19eb9eabff4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-736-24EA - Each63868-736d7e2dd9a-91b4-4f63-b19b-211e75311fc712022-10-06

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-73663868-736-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBITOL506T60A25RIACT
POVIDONEFZ989GH94EIACT
SORBITAN6O92ICV9RUIACT
LIGHT MINERAL OILN6K5787QVPIACT
MANNITOL3OWL53L36AIACT

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
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)fc7954a6-d061-4160-b1d1-a19eb9eabff42024-04-22WarningsExact identifier
ndc (package): 63868-736-24
ndc (product): 63868-736
ndc11 (package): 63868073624
spl id: 6f538aec-efcb-47e0-b483-894647b311db
spl set id: fc7954a6-d061-4160-b1d1-a19eb9eabff4

Reported adverse events (FAERS/openFDA)#

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