Label: COLD AND SINUS MAXIUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hydrochloride liquid

  • NDC Code(s): 53942-515-25
  • Packager: DeMoulas Market Basket
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Drug FactsActive ingredients(in each 20 mL)

    Acetaminophen 650 mg
    Guaifenesin 400 mg
    Phenylephrine HCL 10 mg

  • Purpose

    Pain reliever/Fever reducer
    Expectorant
    Nasal decongestant

  • 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

    Liver warning This product contains acetamnophen. 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 product warfarin.
  • When using this product

    • do not use more that 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 persistant headache. 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.

    Keep out of reach of children.

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

  • 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 dosage cup
    • mL = milliliter
    • do not take more han 6 doses in any 24-hour period

    Age                                                  Dose

    Adults & children                               20 mL every 4 hours
    12 years and older

    Children under 12                             Do not use
    years of age

  • 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&C Blue #1, FD&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 1-877-798-5944

  • Cold and Sinus product label

    Market Basket®
    "MORE FOR YOUR MONEY"
    * COMPARE TO
    the active ingredients found in
    MUCINEX® FAST-MAX™
    COLD & SINUS

    Cold & Sinus
    MAXIUN STRENGTH

    Acetaminophen


    (Pain Reliever/Fever Reducer)

    Guiafenesin (Expectorant)

    Phenylephrine HCL
    (Nasal Decongestant)

    Relieves Fever & Body Aches
    Thins & Loosens Mucus
    Relieves Nasal & Chest Congestion

    Adults For Ages 12 & Over

    LF-009 Rev 01

    6 FL OZ (177 mL)

    Peel Corner to Read Completed Drug Facts and information

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

    Failure to follow these warnings could result in serious consequences.

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

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

    AptaMB ColdSinus 515

    AptaMB ColdSinus 515 1

  • INGREDIENTS AND APPEARANCE
    COLD AND SINUS  MAXIUM STRENGTH
    acetaminophen, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-515
    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) PHENYLEPHRINE10 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:53942-515-25177 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(53942-515)
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