Label: MAXIMUM STRENGTH MAX COLD AND SINUS- acetaminophen, guaifenesin, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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

  • ACTIVE INGREDIENT

    Drug Facts


    Active ingredients
    (in each 20 mL)
    Acetaminophen 650 mg
    Guaifenesin 400 mg
    Phenylephrine HCl   10 mg

  • PURPOSE

    Purpose

    Acetaminophen        Pain reliever/Fever reducer
    Guaifenesin             Expectorant    
    Phenylephrine HCl    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these common cold and flu symptoms:
    • 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

    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 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.
    • 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.
    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
    a breathing problem or chronic cough that lasts or 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
    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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • 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.

  • OVERDOSAGE

    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.

  • DOSAGE & ADMINISTRATION

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

    Age                                         Dose
     Adults & children 12 years and older 20 mL every 4 hours
     Children under 12 years of age Do not use

  • OTHER SAFETY INFORMATION

    Other information
    each 20 mL contains: sodium 10 mg
    dosage cup provided
    store between IS-30°C (59-86°F)
    do not refrigerate

  • INACTIVE INGREDIENT

    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, sorbitol, sucralose, Xanthan gum

  • QUESTIONS

    Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

  • Maximum Strength MAX COLD & SINUS

    AP SAFE                       NDC 76281-515-25

    Compare to Mucinex® FAST-MAX™ Cold & Sinus
    Active ingredients*

    Maximum Strength
    MAX COLD & SINUS

    Acetaminophen /
    Pain reliever/Fever Reducer
    Guaifenesin /Expectorant
    Phenylephrine HCl / Nasal decongestant
    Cold & Sinus

    Relief of:
    • Fever & Bodyaches
    • Thins & Loosens Mucus
    • Nasal & Chest Congestion

    Adults- For Ages 12 and over
    6 FL OZ ( 177 mL)

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
    Failure to follow these warnings could result in serious consequences.

    Manufactured by:
    AptaPharma Inc.,
    1533 Union Ave.
    Pennsauken, NJ 08110

    * This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold &
    Sinus.

    6 Oz 515

    res

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MAX COLD AND SINUS 
    acetaminophen, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 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)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-515-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/30/2024
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-515)