Label: MEDIQUE COLD COUGH PRODUCT- acetaminophen, dextromethorphan hbr, phenylephrine hcl , tablet, film coated

  • NDC Code(s): 47682-108-36, 47682-108-80, 47682-108-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 12, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine Hydrochloride 5 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these common cold/flu symptoms:
    ■ minor aches and pains
    ■ headache
    ■ sore throat
    ■ nasal congestion
    ■ cough
    ■ sinus congestion and pressure
    ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    temporarily reduces fever.

  • WARNINGS

    Warnings

    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

    Allergy alert: acetaminophen may cause a 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:

    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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist.

  • 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 such as occurs with smoking, asthma, 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 dosage.

  • STOP USE

    Stop use and ask a doctor if

    ■ nervousness, dizziness, or sleeplessness occur

    ■ pain gets worse or lasts for 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.

  • 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. 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.

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed (see Warnings)

    Adults and children: (12 years and over)

    ■ take 2 caplets every 4 hours

    ■ do not take more than 12 caplets in 24 hours

    Children under 12 years: do not use this adult product in children under 12 years of age. This will provide more
    than the recommended dose (overdose) and may cause liver damage.

  • OTHER SAFETY INFORMATION

    Other information

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    ■ tamper evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medique®

    Cold & Cough Product

    Multi-Symptom Relief

    Pull to Open

    Pain Reliever/Fever Reducer • Acetaminophen 325 mg

    Cough Suppressant • Dextromethorphan HBr 10 mg

    Nasal Decongestant • Phenylephrine HCl 5 mg

    80 Caplets

    (40 x 2)

    Tamper Evident Unit Dose Packets

    108R Cold

  • INGREDIENTS AND APPEARANCE
    MEDIQUE COLD COUGH PRODUCT 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl , tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Caplet) Size17mm
    FlavorImprint Code AZ;324
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-108-8040 in 1 BOX09/26/2022
    1NDC:47682-108-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-108-3675 in 1 BOX12/12/2022
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/26/2022
    Labeler - Unifirst First Aid Corporation (832947092)