Label: MEDIQUE AT HOME COLD RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

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 March 17, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 325 mg

    Dextromethorphan Hydrobromide 15 mg

    Guaifenesin 200 mg

    Phenylephrine Hydrochloride 5 mg .

  • PURPOSE

    Purpose

    Pain reliever/ fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    ■ for the temporary relief of the following cold/flu symptoms:

    ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough

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

    ■ temporarily reduces fever

  • WARNINGS

    Warnings

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

    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

    ■ for more than 10 days unless directed by a doctor

  • ASK DOCTOR

    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 that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

    ■ cough that occurs with too much phlegm (mucus)

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • WHEN USING

    When using this product do not exceed recommended dose

  • STOP USE

    Stop use and ask a doctor if

    ■ nervousness, dizziness, or sleeplessness occur

    ■ pain, nasal congestion or cough gets worse or lasts for more than 7 days

    ■ fever gets worse or lasts for 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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed (see overdose warning)

    Adults and children12 years and older

    ■ take 2 tablets every 6-8 hours

    ■ swallow whole; do not crush, chew or dissolve

    ■ do not take more than 8 tablets in 24 hours

    Children under 12 years

    ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ store at room temperature 68º-77ºF (20º-25ºC)

    ■ keep this product protected from extremes of moisture, heat and light

    Tamper Evident child resistant packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medique® @ Home

    Multi-Symptom Cold Relief

    Acetaminophen 325 mg • Pain Reliever/ Fever Reducer

    Dextromethorphan Hydrobromide 15 mg • Cough Suppressant

    Guaifenesin 200 mg • Expectorant

    Phenylephrine Hydrochloride 5 mg • Nasal Decongestant

    Pull to Open

    Child-Resistant Packets

    *not actual size

    50 Packets

    (2 Tablets Per Packet)

    MDQ Cold

  • INGREDIENTS AND APPEARANCE
    MEDIQUE AT HOME COLD RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-725
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-725-3350 in 1 BOX02/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/01/2021
    Labeler - Unifirst First Aid Corporation (832947092)