Label: DOLOMAX COLD COUGH- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan 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 December 21, 2017

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

  • Uses:

    temporarily relievess these symptoms due to the common cold:

    • nasal congestion
    • headache
    • minor aches and pains chest congestion
    • cough
    • sore throat
    • helps losen phelgm (mucus) and thin bronchial secretions to drain broncial tubes and makes coughs more productive
    • temporily reduces fever
    Close
  • Active Ingredients

    Active Ingredient (in each tablet)                                       Purpose 
     Acetaminophen 325 mg  Pain Reliever/Fever Reducer
     Guaifenesin 200mg  Expectorant
     Phenylephrine HCl 5mg  Decongestant
     Dextromethorphan HBr 15mg  Antitusive

    Close
  • Warnings

    Liver Warning: this product contains acetaminophen. The maximum daily dose of this product is 8 tablets (2,600 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

    Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, consults a doctor promptly.

    Close
  • Do not use

    • with any other drugs containing acetaminophen (prescription orr non prescription) 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) (certian drugs for depression, psychiatric ie emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains MAOI, ask a doctoror or pharmacist before taking this product.
    • if you have ever had an allergic reactions to this prodcut or any of its ingredients
    Close
  • ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarge prostate gland
    • persistsent r chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much pllegm (mucus)

    ASk a doctor or pharmacist before use if you are taking sedatives, tranquillizers or the blood thinning drug warfarin.

    When using this product do not exceedd recommended dose.

    Close
  • Stop use and ask a doctor if

    • nervouseness, dizziness or sleeplessness occurs
    • oain, cough, or nasal congestion gets worse or last more than 7 days
    • fever gets worse or lasts for more than 3 days
    • redness or sweeling is present
    • new symptons occur
    • cough comes bacj or occurs with rash or headache. These could be signs of a serious condition.
    Close
  • PREGNANCY

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

    Keep out of reach of children.

    Close
  • overdose warning:

    In case of overdose, get madical help or contact a Poison Control Center immediately (1-800-222-1222). Quick medical attention is critival for adults as well as for children even if you do not notice any signs or symptons.

    Close
  • Directions

    do not use more than directed (see overdose warning)
    Adults and children 12 years and over

     take 2 tablets every 6-8 hours.

     do not take more than 8 tablets in 24 hours

    Children under 12 years consult a doctor

    Other Information
    do not use if blister package is torn, cut or open
     store at room temperature  avoid excessive heat and humidity

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium
    Starch Glycolate, Starch, Stearic Acid.

    Questions / COmments: (305)594-0480

    Close
  • KEEP OUT OF REACH OF CHILDREN
  • INDICATIONS & USAGE

    • temporarily relieves these symptoms due to the common cold:
    • nasal congestion
    • headache
    • minor aches and pains chest congestion
    • cough
    • sore throat
    • helps losen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily reduces fever
    Close
  • INGREDIENTS AND APPEARANCE
    DOLOMAX COLD COUGH 
    acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55959-132
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    povidone (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape capsule Size 6mm
    Flavor grape Imprint Code FR12
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55959-132-01 1 in 1 BOX 12/01/2017
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/01/2017
    Labeler - BENARD INDUSTRIES INC (106700321)
    Establishment
    Name Address ID/FEI Business Operations
    BENARD INDUSTRIES INC 106700321 label(55959-132)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc 151051757 manufacture(55959-132)
    Close