DayTime Severe Cold and Flu Relief

Manufacturer
FAMILY DOLLAR SERVICES INC
Effective date
2023-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:44

Label at a glance#

ProductDayTime Severe Cold and Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure11 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 secretions to rid the bronchial pa...

Dosage and administration

• take only as directed • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Storage and handling

• each 15 mL contains: sodium 9 mg • Store at room temperature • Do not refrigerate.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

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 coughs more productive.

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy Alert:

SPL UNCLASSIFIED 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, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persists or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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 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 gets worse or lasts more than 5 days (children) 7 days (adults)
  • 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.

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. 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

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 9 mg
  • Store at room temperature
  • Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C Yellow No. 10, edetate disodium, FD&C Green No. 3, FD&C Red No. 40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Procter & Gamble, distributer of Vicks® Dayquil™ Severe Cold & Flu Honey Flavor

Distributed. by:

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in Vicks® DayQuil™ Severe Cold & Flu Honey Flavor

NDC 55319-061-08

DayTime

Severe

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Guaifenesin – Expectorant

Phenylephrine HCl - Nasal decongestant

Dextromethorphan HBr – Cough suppressant

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Chest Congestion, Thins & Loosens Mucus
  • Nasal Congestion, Sinus Pressure
  • Cough

Honey Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

DayTime Severe Cold & Flu Relief Honey Flavour 8 FL OZ 236 mL
DayTime Severe Cold & Flu Relief Honey Flavour 8 FL OZ 236 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN1
1369842acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD1
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY1
1369842acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY1
1369842APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY1

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
55319-061-082025-01-30C16284748780-12cef2736-a5ea-d83d-e063-dadaa90ab31fDayTime Severe Cold & Flu Relief Honey Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-061-08DayTime Severe Cold and Flu Relief236 mL in 1 BOTTLE, PLASTICLIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-061DAYTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR SERVICES INC]11 package rows20230726_f7abdad5-43ed-425b-bbe6-ec1f8f18ca1c.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-06155319-061-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
f7abdad5-43ed-425b-bbe6-ec1f8f18ca1cf7abdad5-43ed-425b-bbe6-ec1f8f18ca1c2023-07-25WarningsExact identifier
spl id: f7abdad5-43ed-425b-bbe6-ec1f8f18ca1c
spl set id: f7abdad5-43ed-425b-bbe6-ec1f8f18ca1c

Reported adverse events (FAERS/openFDA)#

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