Label: COLD, FLU AND SORE THROAT MAXIUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

  • NDC Code(s): 53942-516-25
  • Packager: DeMoulas Market Basket
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

If you are a consumer or patient please visit this version.

  • Drug FactsActive ingredients (in each 20 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Guaifensin 400 mg
    Phenylephrine HCL 10 mg

  • Purpose

    Pain reliever/Fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Keep out of reach of children

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    temporarily relieves these common cold and flu symptoms:

    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pains
    • sore throat
    • headache
    • fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings

    Liver warning

    This product contains acetaminophen. Sever 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 drugs 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.
    • for children under 12 years of age
  • Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • high blood pressure
    • 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
    • redness or swelling is present
    • symptoms do not get better within 7 days or are accompanied by a fever
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
  • If pregnant or breast feeding

    ask a health professional before use

  • 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

    • take only as recommended (see overdose warning)
    • use dose cup
    • mL = milliliter
    • do not take more than 6 doses in any 24-hour period

    Age - Adults and children 12 years and older       Dose - 20 mL every 4 hours

    Age - Children under 12 years of age                  Dose - Do not use

  • Other information

    • each 20 mL contains: sodium 10 mg
    • dosage cup provided
    • store between 15-30° C (59-86° F)
    • do not refrigerate
  • Inactive ingredients

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

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at

    1-877-798-5944

  • Cold , Flu & Sore Throat product label

    "MORE FOR YOUR DOLLAR"

    MARKET BASKET
    *COMPARE TO THE INGREDIENTS IN MUCINEX® FAST-MAX COLD™, FLU AND SORE THROAT

    Cold, Flu and Sore Throat

    Maximum Strength

    Acetaminophen
    Pain Reliever/Fever Reducer

    Dextromethorophan HBr
    Cough Suppressent

    Guaifenesin Expectorant

    Phenylephrine HCL
    Nasal Decongestant

    Relieves Fever and Body Aches
    Controls Cough
    Thins and Loosens Mucus
    Relieves Nasal and Chest Congestion

    6 FL OZ (177mL)

    Adults
    For Ages 12 and Over

    *This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold, Flu and Sore Throat.
    Peel Corner to Read Complete Drug Facts and Information

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Failure to follow these warnings could result in consequences

    DISTRIBUTED BY
    DEMOULAS SUPERMARKETS INC.
    875 East Street
    Tewksbury, MA 01876

    LB-008 Rev 01

    Lot:
    Exp:

    AptaPharm MB ColdFluST 516

    AptaPharm MB ColdFluST 516 1

    AptaPharm MB ColdFluST 516 2

    res

    AptaPharm MB ColdFluST 516

    AptaPharm MB ColdFluST 516 1

    AptaPharm MB ColdFluST 516 2

  • INGREDIENTS AND APPEARANCE
    COLD, FLU AND SORE THROAT  MAXIUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-516
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-516-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/19/2013
    Labeler - DeMoulas Market Basket (007869647)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(53942-516)