Label: PHYSICIANS CARE NON-DROWSY COLD AND COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

  • NDC Code(s): 0924-0142-00, 0924-0142-01
  • Packager: Acme United
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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

  • Drug Facts

    Drug Facts

  • Active Ingredient

    Active ingredient (in each caplet)

    Acetaminophen 325 mg

    Dextromethorphan Hydrobromide 10 mg

    Guaifenesin 100 mg

    Phenylephrine Hydrochloride 5 mg

  • Purpose

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    Uses

    Temporarily relieves these cold symptoms

    • cough
    • sore throat
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

    Temporarily reduces fever.

  • Warnings

    Warnings

    Liver warning: This product contains acetaminophen. 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 have ever had an allergic reaction to this product or any of its ingredients
    • 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

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin.
  • When using this product do not exceed recommended dosage.

    When using this product do not exceed recommended dosage.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    • new symptons occur
    • redness or swelling is present
    • pain, cough or nasal congestion gest worse or lasts for more than 7 days
    • fever gets worse or lasts more than 3 days
    • nervousness, dizziness, or sleeplessness 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.

    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 overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Directions

    • do not take more than directed

    Adults and children: (12 years and older)

    Take 2 caplets every 4 hours
    Do not to take more than 10 caplets in 24 hours

    Children under 12 years: ask a doctor

  • Other 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 ingredients

    Inactive ingredients

    corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions

    Questions? 1-800-835-2263

  • Physicians Care Cold & Cough

    91462

    PhysiciansCare®

    Non-Drowsy

    Cold & Cough

    Cold, Cough and Flu Relief

    Pull

    to Open

    COATED CAPLET

    Individually packaged for workplace use

    Tamper-Evident Packets of 2 Caplets

    Do not use if packet is open or torn.

    Not Actual Size

    100 Caplets (50 Packets, 2 caplets each)

    435R 91462 8082980revA 7-22-22

  • INGREDIENTS AND APPEARANCE
    PHYSICIANS CARE NON-DROWSY COLD AND COUGH 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0142
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULE ((Caplet)) Size17mm
    FlavorImprint Code 44;546
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0142-0150 in 1 BOX01/19/2023
    1NDC:0924-0142-002 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/19/2023
    Labeler - Acme United (001180207)
    Registrant - Unifirst First Aid Corportaion (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(0924-0142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(0924-0142)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International832867837manufacture(0924-0142)