Label: COLD MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 2, 2019

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

  • Active ingredient(s)

    Acetaminophen 325mg

    Dextromethorphan HBr 10mg

    Phenylephrine HCl 5mg

  • Purpose

    Pain reliever/fever reducer

    Cough supressant

    Nasal decongestant

  • Uses

    ■ temporarily relieves these common cold/flu symptoms:

    ■ minor aches and pains 

    ■ headache 

    ■ sore throat  

    ■ nasal congestion 

    ■ cough  

    ■ sinus congestion and pressure 

    ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 

    ■ temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if you take: 

    ■ more than 12 caplets in 24 hours, which is the maximum daily amount 

    ■ 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 immediately

    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 products containing acetaminophen (prescription or nonprescription).

    If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist  n 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 drugs. If you do not know if your prescription drugs contains an MAOI, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    ■ liver disease 

    ■ heart disease n high blood pressure 

    ■ thyroid disease 

    ■ diabetes 

    ■ trouble urinating due to an enlarged prostate gland 

    ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema n cough that occurs with too much phlegm (mucus)

    Ask a doctor before use if you are

    taking the blood thinning drug warfarin

    When using this product

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    Stop use and ask a doctor if        

    ■ nervousness, dizziness or sleeplessness occurs 

    ■ pain gets worse or lasts more than 7 days n fever gets worse or lasts more than 3 days  

    ■ redness or swelling is present  n new symptoms occur  

    ■ cough comes back or occurs with rash or headache that lasts 

    These could be signs of a serious condition.

    Pregnancy/Breastfeeding

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

    Keep out of reach of children

    Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)

    Adults and children 12 years and over: 

    ■ take 2 caplets every 4 hours   

    ■ do not take more than 12 caplets in 24 hours 

    Children under 12 years: do not use this adult product in children under 12 years of age.

    This will provide more than the recommended dose (overdose) and may cause liver damage

  • Other information

    ■ store between 15-30°C (59-86°F) 

    ■ do not use if blister is torn or open

  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropylmethylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

  • Questions or comments?

    Call toll free 1-888-952-0050

  • Principal Display Panel

     Cold Multi-Symptom

    Cold Multi-Symptom

  • INGREDIENTS AND APPEARANCE
    COLD MULTI-SYMPTOM 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-324
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ;324
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-324-861 in 1 CARTON08/15/2015
    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 NOT FINALpart34308/15/2015
    Labeler - Allegiant Health (079501930)