Label: COLD AND COUGH- acetaminophen and dextromethorphan hydrobromide liquid 

  • 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 08/14

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

  • Active ingredients (in each 15 mL = 1 tablespoon)

    Acetaminophen 500 mg

    Dextromethorphan HBr 15 mg

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  • Purpose

    Pain reliever

    Cough suppressant

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  • Uses

    temporarily relieves:
    sore throat
    minor aches and pains
    headache
    cough due to a cold
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  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoons (3,000 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

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

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    pain 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: Taking more than the recommended dose (overdose) may cause liver damage. 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

    do not take more than directed (see overdose warning)
    use only enclosed dosing cup designed for this product. Do not use any other dosing device.

    adults & children 12 years & over

    take 30 mL (2 TBSP) in dose cup provided every 6 hours
    do not take more than 6 tablespoons in 24 hours

    children under 12 years

    ask a doctor
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  • Other information

    each tablespoon contains: potassium 25 mg and sodium 8 mg
    store at 20-25°C (68-77°F)
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  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue #1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    DAYTIME

    NON-DROWSY

    Cold & Cough

    Acetaminophen / Sore Throat / Body Aches / Headache

    Dextromethorphan HBr / Coughing

    Pain reliever & cough suppressant

    COOL ICE®

    INSTANT COOLING SENSATION

    8 FL OZ (237 mL) LIQUID

    Compare to Tylenol® Cold & Cough active ingredients

    Walgreens Cold & Cough Image 1
    Walgreens Cold & Cough Image 2
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  • INGREDIENTS AND APPEARANCE
    COLD AND COUGH 
    acetaminophen, dextromethorphan hbr liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0698
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    ANHYDROUS CITRIC ACID  
    CARBOXYMETHYLCELLULOSE SODIUM  
    FD&C BLUE NO. 1  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    SUCROSE  
    Product Characteristics
    Color BLUE (clear) Score     
    Shape Size
    Flavor MENTHOL Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0698-34 237 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/09/2011
    Labeler - Walgreen Company (008965063)
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