FDA.reportPublic FDA data

Severe Cold and Flu Relief Daytime - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-19 01:00:54

Label at a glance#

ProductSevere Cold and Flu Relief Daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

take only as directed (see overdose warning) do not take more than 4 doses in 24 hours measure only with dosing cup provided. Do not use any other dosing device mL = milliliter keep dosing cup with product when using other Daytime or Nighttime products, carefully read each label to insure correct dosing adults and children12 years and over 30 mL every 4 hours  children 6 to under 12 years  15 mL every 4 hours  chi...

Label contents#

Full prescribing information#

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

Warnings

WARNINGS SECTION

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

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blistere
  • 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 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 an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if user is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not take more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • new symptoms occur 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present  
  • 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 can cause serious 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 and 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 take more than 4 doses in 24 hours
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL = milliliter
  • keep dosing cup with product
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
adults and children12 years and over30 mL every 4 hours 
children 6 to under 12 years 15 mL every 4 hours 
children 4 to under 6 years ask a doctor 
children under 4 years do not use 

Other information

OTHER SAFETY INFORMATION

  • each 15 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate sodium chloride, sodium citrate, sorbitol sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-309-9030

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients of VICKS® DAYQUIL™ Severe Cold & Flu

Day Time

Severe Cold & Flu Relief 

Acetaminophen 325 mg

 Pain Reliever/Fever reducer

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

Phenylephrine HCI 5 mg

Nasal decongestant

  • Headache, fever, sore throat, minor aches & pains
  • Nasal / sinus congestion & sinus pressure
  • Cough
  • Chest congestion

For ages 6 years and over

Max strength 

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

TAMPER EVIDENT: DO NOT USE IF PRINITED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOLLAR GENERAL HEALTH Daytime Severe Cold & Flu Relief
DOLLAR GENERAL HEALTH Daytime Severe Cold & Flu Relief

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

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
55910-51555910-515-08

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
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-09-05full-release2026-06-01 00:18:56

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
4539e4e0-b223-4cfa-87d7-42a98390101a91cd42fb-0aaf-4e83-b99c-9c521f93e8742024-09-05WarningsExact identifier
spl set id: 91cd42fb-0aaf-4e83-b99c-9c521f93e874

Reported adverse events (FAERS/openFDA)#

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