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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 5, 2021

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 finalpart34107/05/2021
    Labeler - BENARD INDUSTRIES INC (106700321)