Label: UNISHIELD COUGH AND COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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

    Guaifenesin 100 mg

    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    Temporarily relieves these symptoms due to the common cold:
    ■ headache
    ■ nasal congestion
    ■ cough
    ■ minor aches and pains
    ■ sore throat
    ■ sinus congestion and pressure
    ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and 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 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 a severe skin reactions. Symptoms may include:

    ■ blisters

    ■ rash

    ■ skin reddening

    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 DOCTOR

    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 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, cough or nasal congestion 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 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.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ do not take more than directed

    Adults and children: (12 years and over)

    ■ take 2 caplets every 4 hours

    ■ not to take more than 10 caplets in 24 hours

    Children under 12 years: ask a doctor

  • 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

    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 or comments? 800-480-5855

  • PRINCIPAL DISPLAY PANEL

    Unishield

    Cough & Cold

    Multi-Symptom

    80 Caplets / 2 Caplets Per Packet

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 100 mg

    Phenylephrine HCl 5 mg

    Pull To Open

    This Package is for Households Without Young Children.

    • Pain reliever/fever reducer

    • Quiets coughs

    • Losens phlem and thins bronchial secretions

    • Relieves sinus congestion

    Relieves coughs, minor aches, headache, congestions & fever

    Tamper Evident Unit Dose Packets

    Unishield 435R

  • INGREDIENTS AND APPEARANCE
    UNISHIELD COUGH AND COLD 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-4358
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
    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
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULE (caplet) Size17mm
    FlavorImprint Code 44;546
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-4358-040 in 1 BOX09/26/2022
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/26/2022
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)