FDA.reportPublic FDA data

Daytime Severe Cold and Flu Relief Softgels

Manufacturer
Wal-Mart Stores Inc | Spirit Pharmaceuticals LLC | MEDGEL PRIVATE LTD
Effective date
2021-11-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:25:23

Label at a glance#

ProductDaytime Severe Cold and Flu Relief Softgels
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 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 ...

Dosage and administration

■ take only as directed ■ do not exceed 8 softgels per 24 hours   adults & children 12 years & over  2 softgels with water every 4 hours  children 4 to under 12 years  ask a doctor  children under 4 years  do not use  ■ when using other Nighttime or Daytime 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

Guaifenesin 200 mg

Phenlyephrine 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: 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

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

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 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,

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 liver damage. In case of overdose, get medical help or contact a Poison Control Center 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

■ take only as directed
■ do not exceed 8 softgels per 24 hours 

 adults & children 12 years
& over 		 2 softgels with water
every 4 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use

 ■ when using other Nighttime or Daytime products,
carefully read each label to ensure correct dosing

Other information

OTHER SAFETY INFORMATION

  • ■ store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?1-888-287-1915

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Vicks® DayQuil® Cold & Flu*

MAXIMUM STRENGTH

Daytime Softgels

Severe Cold/Flu Relief

ACETAMINOPHEN - Pain reliever; fever reducer

DEXTROMETHORPHAN HBr - Cough Suppressant

GUAIFENESIN- Expectorant

PHENYLEPHRINE HCl - Nasal Decongestant

Relieves:
Headache, Fever, Sore throat, Minor aches
& pains, Cough, Chest congestion, Nasal/Sinus
congestion & Sinus pressure
Non-drowsy
Alcohol free
Antihistamine free

24 SOFTGELS

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® DayQuil® Severe Cold & Flu

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-617-242023-12-06C16284748780-1f386c649-acb5-0266-e053-dadaa90a7c1aDaytime Severe Cold and Flu Relief
49035-617-242023-01-30C16284748780-1f386c649-acb5-0266-e053-dadaa90a7c1aDaytime Severe Cold and Flu Relief

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
49035-61749035-617-24

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
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
2a800ac4-addc-43f3-e063-6294a90a35a535a83e54-53c2-4435-81a4-f92fe448e9252024-12-30WarningsExact identifier
spl set id: 35a83e54-53c2-4435-81a4-f92fe448e925

Reported adverse events (FAERS/openFDA)#

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