Label: COLD MULTI-SYMPTOM NIGHT-TIME- acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci 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 26, 2018

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

  • Active ingredient

    Acetaminophen 325 mg
    Chlorpheniramine maleate 2 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCI 5 mg

  • Purpose

    Pain reliever/fever reducer
    Antihistamine
    Cough suppressant
    Nasal decongestant

  • Uses

    temporarily relieves these common cold/flu symptoms:

    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • sneezing and runny nose
    • sinus congestion and pressure
    • helps clear nasal passages
    • relieves cough to help you sleep
    • temporarily reduces fever
  • Warnings

    Liver warning/Allergy alert

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets

    (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
    • with other drugs containing acetaminophen

    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

    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 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, 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 drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occurs
    • 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 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 Overdose Warnings)

    Adults and children 12 years and over:

    • take 2 caplets every 4 hours
    • swallow whole; do not crush, chew or dissolve
    • do not take more than a total of 10 caplets in 24 hours

    Children under 12 years: ask a doctor

  • Other Information

    • store at room temperature 20°– 25°C (68°– 77°F)
    • do not use if blister is torn or open
  • Inactive Ingredients

    corn starch, crospovidone, croscarmellose
    sodium, FD&C blue #1 aluminum lake, hypromellose, magnesium
    stearate, microcrystalline cellulose, povidone, pregelatinized starch,
    polyethylene glycol, silicon dioxide, stearic acid, itanium dioxide

    May contain: FD&C lake black

  • Questions or comments?

    Call toll free 1-888-952-0050 Monday through Friday 

  • Package/Label Principal Display Panel

    Cold Multi-symptom

    Cold Multi-symptom

  • INGREDIENTS AND APPEARANCE
    COLD MULTI-SYMPTOM  NIGHT-TIME
    acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-319
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ319
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-319-8612 in 1 BLISTER PACK; Type 0: Not a Combination Product12/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/23/2014
    Labeler - Allegiant Health (079501930)