FDA.reportPublic FDA data

Winco Foods Fast Acting Mucus Relief Cold, Flu & Sore Throat Maximum Strength

Manufacturer
WINCO FOODS, LLC
Effective date
2026-08-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-11 01:01:14

Label at a glance#

ProductWINCO Maximum StrengthCold Flu and Sore Throat
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves these common cold and flu symptoms: • cough • nasal congestion • minor aches and pain • sore throat • headache • stuffy nose • sinus congestion and pressure • temporarily reduces fever • temporarily 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

Dosage and administration

• do not take more than directed (see Overdose warning) • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided. • do not use dosing cup with other products   • dose as follows or as directed by a doctor • mL = milliliter • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours • children under 12 years of age: Do not use

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg 

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pain
    • sore throat
    • headache
    • stuffy nose
    • sinus congestion and pressure
  • temporarily reduces fever
  • temporarily 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 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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.
  • for children under 12 years of age
  • 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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis 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

  • nervousness, dizziness or sleeplessness occur
  • 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 fever, 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 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

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided.
  • do not use dosing cup with other products  
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: Do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 20 mL contains: sodium 8 mg
  • store at room temperature
  • do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-824-1706

Monday-Friday 9am – 4pm MST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Maximum Strength MUCINEX® FAST-MAX® Cold, Flu & Sore Throat

Winco® Foods

Fast Acting Mucus Relief

COLD, FLU & SORE THROAT

Maximum Strength‡

Acetaminophen650 mg/ PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr 20 mg/ COUGH SUPPRESSANT

GUAIFENESIN 400 mg/ EXPECTORANT

PHENYLEPHRINE HCI 10 mg/ NASAL DECONGESTANT

Adult Formula, For Ages 12 & Over

4 Hour Dosing

6 FL OZ (180 mL)

*This product is not manufactured or distributed by RECKITT BENCKISER, the distributor of Maximum Strength‡ MUCINEX® FAST-MAX® Cold, Flu & Sore throat.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

‡Per 4-hour dose.

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

*This product is not manufactured or distributed by Reckitt Benckiser, the distributer of Maximum Strength Mucinex® Fast-Max™ Cold, Flu & Sore Throat.

PEEL CORNER TO READ COMPELETE DRUG FACTS AND INFORMATION

Winco Foods Fast Acting Mucus Relief
Winco Foods Fast Acting Mucus Relief

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

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
67091-45767091-457-06

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-02full-release2026-06-01 01:19:11

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
WINCO Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWINCO FOODS, LLCf34bfb71-2c81-44d0-a2a0-4d320c43c2172026-08-07WarningsExact identifier
ndc (package): 67091-457-06
ndc (product): 67091-457
ndc11 (package): 67091045706
spl id: 2d046eef-7013-4f9e-814e-585f04f6ad0c
spl set id: f34bfb71-2c81-44d0-a2a0-4d320c43c217

Reported adverse events (FAERS/openFDA)#

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