Cold and Flu

Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Effective date
2022-09-27
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:52:48

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 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

butylated hydroxyanisole*, butylated hydroxytoluene* FD&C red #40*,FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide*, white ink

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-287-1915

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare Vicks® DayQuil® Cold & Flu LiquiCaps® active ingredients†

DAYTIME NON-DROSWY

Cold & Flu

Multi-Symptom Relief

Acetaminophen 325 mg-Pain reliever/fever reducer

Dextromethorphan HBr 10 mg - cough suppressant

Phenylephrine HCl 5 mg - Nasal decongestant

Relieves:

  • Headaches
  • Fever
  • Minor Aches & Pains
  • Sore throat
  • Cough
  • Nasal Congestion

Alcohol-free Antihistamine-free

SOFTGELS**

(**Liquid-filled capsules)

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: 

Walmart  Inc.,

Bentonville, AR 72716

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUATE Cold and Flu Relief
EQUATE Cold and Flu Relief

FDA-Initiated Inactive NDC Indexing#

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
49035-54249035-542-48, 49035-542-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
fc0ae3ea-8ac8-4a76-b117-46286b99534f3b1dfc1a-1706-48e5-ae0d-9690fe3e22df2022-09-27WarningsExact identifier
spl id: fc0ae3ea-8ac8-4a76-b117-46286b99534f
spl set id: 3b1dfc1a-1706-48e5-ae0d-9690fe3e22df

Reported adverse events (FAERS/openFDA)#

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