Label: DOLOMAX COLD COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

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

Drug Label Information

Updated October 31, 2024

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

  • Drug Facts

  • Active ingredients (in each tablet)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain Reliever
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    For the temporary relief of the following cold/flu symptoms:
    • minor aches and pains  • headache  • sore throat  • nasal congestion  • cough 
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 
    • temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen.
    The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours.
    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if 
    • liver 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 blood thinning drug warfarin

    When using this product do not exceed recommended dose

    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 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: 
    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)

    adults and children 12 years and over• take 2 tablets every 4 hours
    • swallow whole; do not crush, chew or dissolve
    • do not take more than 10 tablets in 24 hours 
    children under 12 yearsask a doctor

  • Other information

    each tablet contains: sodium 2 mg  • store at 20°-25°C (68°-77°C)

  • Inactive ingredients

    croscarmellose sodium, D&C Yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

  • Questions or comments?

    1.800.595.0480 Mon-Fri: 9 AM to 4 PM

  • SPL UNCLASSIFIED SECTION

    SEE NEW WARNINGS INFORMATION & DIRECTIONS

    Cold/Cough Medicine

    OTC EXCELLENCE IN NUTRITIONTM

    › Head & Body Aches
    › Nasal Congestion
    › Fever
    › Sore Throat
    › Cough
    › Sinus Pain

    READ AND KEEP CARTON FOR NEW WARNINGS INFORMATION & DIRECTIONS.

    SEE ACETAMINOPHEN WARNINGS

    RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF BLISTER IS CUT OR BROKEN

    Distributed by
    OTC Pharmaceutical Products
    10860 Nw 27th St , Doral , FL 33172

    www.otcpharmausa.com

  • Packaging

    DoloMaxCold-133

  • INGREDIENTS AND APPEARANCE
    DOLOMAX COLD COUGH 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55959-133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Coloryellow (light yellow) Scoreno score
    ShapecapsuleSize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55959-133-011 in 1 BOX07/05/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/05/2021
    Labeler - BENARD INDUSTRIES INC (106700321)