Label: COLD MAX DAY AND NIGHT- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride kit

  • NDC Code(s): 83324-093-20
  • Packager: CHAIN DRUG MARKETING ASSOCIATION, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 7, 2024

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

  • SPL UNCLASSIFIED SECTION

    COLD MAX DAY

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each Day caplet)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant

  • Uses

    • temporarily relieves these common cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • cough
      • sinus congestion and pressure
    • helps clear nasal passages
    • promotes nasal and sinus drainage
    • temporarily reduces fever
  • SPL UNCLASSIFIED SECTION

    COLD MAX NIGHT

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each Night caplet)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Chlorpheniramine maleate 2 mgAntihistamine
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant

  • Uses

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

    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

    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 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)
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    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

    In addition, when using Cold Max Night:

    • 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 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)
    • do not take Day and Night caplets at the same time
    • do not take more than a total of 10 caplets in 24 hours
    adults and children
    12 years and over
    • take 2 caplets every 4 hours
    • swallow whole – do not crush, chew, or dissolve
    children under
    12 years
    • ask a doctor

  • Other information

    • store between 20-25°C (68-77°F) in a dry place
    • retain carton for complete product information and warnings
  • Inactive ingredients

    Cold Max Day

    acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

    Cold Max Night

    acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    QUALITY CHOICE®

    NDC 83324-093-20

    Cold Max Day & Night

    For Adults

    Acetaminophen,Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate*

    Pain Reliever | Fever Reducer, Cough Suppressant, Nasal Decongestant, Antihistamine*

    For Relief of:

    Headache + Body Aches

    Fever + Sore Throat

    Nasal Congestion

    Cough

    Runny Nose*

    *Antihistamine in Nighttime Only

    12 DAY / 8 NIGHT CAPLETS

    DAY Actual Size

    NIGHT Actual Size

    20 COOL TASTE CAPLETS

    image description

  • INGREDIENTS AND APPEARANCE
    COLD MAX DAY AND NIGHT 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-093
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-093-201 in 1 CARTON08/07/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK
    Part 1 of 2
    ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated
    Product Information
    Item Code (Source)NDC:83324-182
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorMINTImprint Code AAA;1138
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 DrugM012
    Part 2 of 2
    ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated
    Product Information
    Item Code (Source)NDC:83324-119
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorMINTImprint Code AAA;1139
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/07/2024
    Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774)