FAST ACTING COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [WINCO FOODS, LLC.]

FAST ACTING COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [WINCO FOODS, LLC.]
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NDC 67091-331-06
Set ID 2dfa5df2-8646-4ed2-8720-a29f95964dea
Category Human OTC Drug Label
Packager Winco Foods, LLC.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

    Active ingredients (in each 20 mL (4 tsp) dose)

    Acetaminophen, USP 650 mg
    Dextromethorphan HBr, USP 20 mg
    Guaifenesin, USP 400 mg
    Phenylephrine HCl, USP 10 mg

  • Purposes

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • cough
      • nasal congestion
      • sinus congestion and pressure
      • minor aches and pains
      • sore throat
      • headache
    • 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

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily 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

    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients Avoid foods or beverages that contain caffeine
  • Ask a doctor before use if you have

    • 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 taking the blood thinning drug warfarin
  • When using this product

    • do not use more than directed
  • Stop use and ask a doctor if

    • 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,

    ask a health professional before use.

  • Keep out of reach of children.

    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 (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

    • do not take more than directed (see Overdose warning)
    • 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; tsp = teaspoon
    • adults and children 12 years of age and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
    • children under 12 years of age: do not use unless directed by a doctor
  • Other information

    • Each 20 mL contains: sodium 12 mg
    • Store at 20-25°C (68-77°F)
    • tamper evident: do not use if printed seal under cap is torn or missing
    • do not refrigerate
    • dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

  • Questions?

    Call 800-824-1706 Monday - Friday 9am - 4pm  MST

    DISTRIBUTED BY:
    WINCO FOODS, LLC,
    BOISE, ID 83704

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)

    *Compare to the active ingredients in MUCINEX®
    FAST-MAXTM Cold, Flu & Sore Throat

    Winco®
    Foods


    MAXIMUM STRENGTH

    Fast Acting
    Cold, Flu & Sore
    Throat Relief
    Multi-Symptom

    ACETAMINOPHEN 650 mg/
    PAIN RELIEVER - FEVER REDUCER
    DEXTROMETHORPHAN HBr 20 mg/
    COUGH SUPPRESSANT
    GUAIFENESIN 400 mg/EXPECTORANT
    PHENYLEPHRINE HCI 10 mg/
    NASAL DECONGESTANT

    For Ages 12 & Over

    4 Hour Dosing

    6 FL OZ (180 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    FAST ACTING COLD, FLU AND SORE THROAT RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUE (Blue to Bluish Green) Score    
    ShapeSize
    FlavorBERRY, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-331-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product08/11/201506/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/11/201506/22/2022
    Labeler - Winco Foods, LLC. (056098817)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(67091-331)

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