Label: MAX COLD, FLU, AND SORE THROAT- acetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl liquid

  • 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 Facts Active ingredients

    Active ingredients (in each 20 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Guaifenesin 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 awaay.

  • 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 loosed phlegm (mucus) ang thin bronchial secretions to drain bronchial tubes

  • 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

    Allery Alert: Acetaminophen may cause
    severe skin reaction. 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 taking  a prescription monamine 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 or empysema
    • 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 the 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

    Age                                                                                  Dose

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

    Children under 12 years of age                                           Do not use


  • Other information

    • each 20 mL contains: sodium 10 mg
    • dosage cup provided
    • store between 20°-25° C (68°-7°7 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

  • Product Label

    Compare to Mucinex® FAST-MAX™ 

    Cold, Flu & Sore Throat active ingredients*

                                        NDC 37808-316-25

    H E B®

    Maximum Strength

    MAX COLD, FLU & SORE THROAT

    Acetaminophen /
    (Pain Reliver/Fever Reducer)
    Dextromethorphan HBr /
    (Cough Suppressant)
    Guaifensin / (Expectorant)
    Phenylephrine HCL /
    Nasal Decongestant)

    Cold, Flu & Throat


    Relief of:
    • Fever and Body aches
    • Controls Cough
    • Thins and Loosens Mucus
    • Relieves Nasal and Chest Congestion

    Adults
    For ages 12 and Over

    6 FL OZ (117 mL)              LF-002 Rev.2 02

    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

    100%
    GUARANTEE
    promise

    If you aren't completely pleased
    with this product, we’ll be happy to
    replace it or refund your money.
    You have our word on it.

    LB-002 Rev 02

                   1208

    Lot:
    Exp:


    HEB MaxCold pg1

    HEB MaxCold pg2

    HEB MaxCold pg3

  • INGREDIENTS AND APPEARANCE
    MAX COLD, FLU, AND SORE THROAT 
    acetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-316
    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:37808-316-25117 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/05/2014
    Labeler - H E B (007924756)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(37808-316)