Label: COLD RELIEF SEVERE PAIN COUGH- acetaminophen,guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide 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 October 15, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients

    Acetaminophen 325 mg.Guaifenesin 200 mg Phenylephrine HCl 5 mg


  • PURPOSE

    Pain Reliever, Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant

  • DOSAGE & ADMINISTRATION

    Directions: adults and children 12 years of age and over • take 2 tablets with water every 6-8 hours, as needed • do not take more than 8 tablets in 24 hours children under 12 years of age • do not give to children under 12 years of age

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount, for this product • 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 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. • with any other product containing any of the above active ingredients • 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. Ask a doctor before use if you have • liver disease • heart 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 the blood thinning drug warfarin • taking sedatives or tranquilizers When
    using this product • do not exceed recommended dosage • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase the drowsiness effect • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • nervousness, dizziness,or sleeplessness occur • pain or 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.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    MM1

    cold relief severe packet

  • INGREDIENTS AND APPEARANCE
    COLD RELIEF SEVERE PAIN COUGH  
    acetaminophen,guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-456
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (FR12) Size12mm
    FlavorImprint Code FR12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-456-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Labeler - Select Corporation (053805599)