FDA.reportPublic FDA data

Multi-Symptom Daytime Liquid Capsules 10 softgels

Manufacturer
Greenbrier International, Inc.
Effective date
2017-12-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:12

Label at a glance#

ProductMulti Symptom Daytime
Active ingredientACETAMINOPHEN, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Label structure11 sections

Indications and uses

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

Dosage and administration

• take only as directed - see Overdose Warning • do not exceed 4 doses per 24 hours adults & children 12 years and over 2 Softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Storage and handling

• store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Boxed Warning section

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

SPL UNCLASSIFIED SECTION

Purposes

OTC - PURPOSE SECTION

Boxed Warning section

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

SPL UNCLASSIFIED SECTION

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Allergy alert

ADVERSE REACTIONS SECTION

  • 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

SPL UNCLASSIFIED SECTION

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

SPL UNCLASSIFIED SECTION

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed - see Overdose Warning
  • do not exceed 4 doses per 24 hours

adults & children 12 years and over

2 Softgels with water every 4 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-952-0050

SPL UNCLASSIFIED SECTION


Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

PRINCIPAL DISPLAY PANEL - 10 Softgel Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED

COMPARE TO ACTIVE INGREDIENTS IN VICKS ®DAYQUIL®

Multi-Symptom

DayTime

Liquid Capsules

  • Acetaminophen- Pain Reliever/Fever Reducer
  • Dextromethorphan HBr- Cough Suppressant
  • Phenylephrine HCl -Nasal Decongestant

Fever, Headache, Sore Throat, Coughing, Minor Aches and Pains, & Nasal congestion

10 Softgels

COMPARE TO ACTIVE INGREDIENT IN VICKS DAYQUIL®

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Procter & Gamble distributor of Vicks®DayQuil® Cold &Flu LiquiCaps®

Multi-Symptom Daytime Liquid Capsules 10 Softgels
Multi-Symptom Daytime Liquid Capsules 10 Softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-6110-12020-01-31C16284748780-19d75b9d0-6fb5-f424-e053-dadaa90a57ceMulti-Symptom Daytime Liquid Capsules 10 softgels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-6110-1Multi Symptom Daytime1 in 1 CARTONCAPSULE, LIQUID FILLED11
33992-6110-1Multi Symptom Daytime10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-6110MULTI SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [GREENBRIER INTERNATIONAL, INC.]1Legacy NDC, 2 package rows20180119_c2cbc647-e5d9-43c7-9f6c-b808032191c5.zip

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
33992-611033992-6110-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
FD&C Red No. 40WZB9127XOAIACT
FD&C Yellow No. 6H77VEI93A8IACT
gelatin2G86QN327LIACT
glycerinPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
polyethylene glycols3WJQ0SDW1AIACT
POVIDONESFZ989GH94EIACT
propylene glycol6DC9Q167V3IACT
water059QF0KO0RIACT
sorbitol506T60A25RIACT
titanium dioxide15FIX9V2JPIACT

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
c2cbc647-e5d9-43c7-9f6c-b808032191c5c2cbc647-e5d9-43c7-9f6c-b808032191c52017-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: c2cbc647-e5d9-43c7-9f6c-b808032191c5
spl set id: c2cbc647-e5d9-43c7-9f6c-b808032191c5

Reported adverse events (FAERS/openFDA)#

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