Label: COLD RELIEF- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl

  • NDC Code(s): 56062-496-04
  • Packager: Publix Super Markets Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/12

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

  • Active ingredient (in each caplet) (NIGHT)

    Acetaminophen 325 mg

    Chlorpheniramine maleate 2 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

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  • Active ingredient (in each caplet) (DAY)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

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  • Purpose (NIGHT)

    Pain reliever

    Antihistamine

    Cough suppressant

    Nasal decongestant

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  • Purpose (DAY)

    Pain reliever

    Cough suppressant

    Nasal decongestant

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  • Uses (NIGHT)

    • temporarily relieves these common cold symptoms:
    • headache
    • nasal congestion
    • minor aches and pains
    • cough
    • sore throat
    • sinus congestion and pressure
    • sneezing and runny nose
    • helps clear nasal passages
    • relieves cough to help you sleep
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  • Uses (DAY)

    • temporarily relieves these common cold symptoms:
    • headache
    • nasal congestion
    • minor aches and pains
    • cough
    • sore throat
    • sinus congestion and pressure
    • helps clear nasal passages
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  • Warnings (NIGHT)

    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

    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.
    • to make a child sleepy

    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
    • cough that lasts or is chronic 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 sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    • do not use more than directed
    • 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

    • you get nervous, dizzy or sleepless
    • 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.

    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.

    Close
  • Warnings (DAY)

    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

    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.

    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
    • cough that lasts or is chronic 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

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • 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.

    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.

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  • Directions (NIGHT)

    • do not take more than directed (see Liver warning)
    • do not take the Day and Night caplets at the same time
    • do not take more than a total of 12 caplets in 24 hours
    adults and children 12 years and over
    • take 2 caplets every 4-6 hours
    • swallow whole – do not crush, chew or dissolve
    children under 12 years do not use this adult product in children under 12 years of age
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  • Directions (DAY)

    • do not take more than directed (see Liver warning)
    • do not take the Day and Night caplets at the same time
    • do not take more than a total of 12 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

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

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  • Inactive ingredients (NIGHT)

    acesulfame potassium, blue no. 1 lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

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  • Inactive ingredients (DAY)

    acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide

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  • Principal Display Panel

    SEE NEW WARNINGS INFORMATION

    HEAD CONGESTION

    coldrelief

    PAIN RELIEVER, NASAL DECONGESTANT

    COUGH SUPPRESSANT, ANTIHISTAMINE

    DAYTIME

    ACETAMINOPHEN

    DEXTROMETHORPHAN HBr

    PHENYLEPHRINE HCl

    ACTUAL SIZE

    NIGHTTIME

    ACETAMINOPHEN

    CHLORPHENIRAMINE MALEATE

    DEXTROMETHORPHAN HBr

    PHENYLEPHRINE HCl

    Antihistamine in Nighttime only

    ACTUAL SIZE

    Compare to the Active Ingredients in Tylenol® Cold Head Congestion Day and Night Caplets

    Cold Relief Carton Image 1

    Cold Relief Carton Image 1

    Cold Relief Carton Image 2

    Cold Relief Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    COLD RELIEF 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:56062-496
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:56062-496-04 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BLISTER PACK 12 
    Part 2 1 BLISTER PACK 12 
    Part 1 of 2
    NIGHTTIME COLD 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    POVIDONE  
    WATER  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE (Light Blue) Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code L393
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 in 1 KIT
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/03/2007
    Part 2 of 2
    COLD  DAYTIME
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    CARNAUBA WAX  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    POVIDONE  
    SILICON DIOXIDE  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code L402
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 in 1 KIT
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/26/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/26/2009
    Labeler - Publix Super Markets Inc (006922009)
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