Label: XPECT COLD RELIEF- acetaminophen guaifenesein phenylephrine hcl tablet

  • NDC Code(s): 42961-112-10, 42961-112-11, 42961-112-12
  • Packager: Cintas Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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

  • Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache, nasal congestion, minor aches and pains, sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 
    • temporarily reduces fever
  • 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: blisters, rash, skin reddening. If a skin reaction occurs, stop use and seek medical help right away. 

  • 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

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • heart disease
    • thyroid disease
    • diabetes
    • liver disease
    • high blood pressure
    • difficulty in urination due to enlargement of the prostate gland
  • 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.

  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, 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.
  • 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, 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

    • do not take more than directed
    • adults and children 12 years and over: take 2 caplets every 4 hours; swallow whole - do not crush, chew, or dissolve; do not take more than 10 caplets in 24 hours 
    • children under 12 years: ask a doctor
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see package for expiration date and lot number
  • Inactive ingredients

    corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glyvol, polyvinyl alcohol, povidone, silicone dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

  • Questions? 

    1-877-973-2811 Monday-Friday 8:00 AM-5:00 PM

  • Principal Display Panel - Wrapper

    COLD RELIEF

    Acetaminophen • Pain Reliever/Fever Reducer

    Guaifenesin • Expectorant

    Phenylephrine HCl • Nasal Decongestant

    2 CAPLETS PER PACKET

    DO NOT USE IF PACKET IS DAMAGED OR OPEN

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    wrapper-01

  • Principal Display Panel - 80 count Box

    COLD RELIEF

    Active Ingredients:

    Acetaminophen

    Guaifenesin

    Phenyleprine HCl

    Pain Reliever/Fever Reducer

    Expectorant

    Nasal Decongestant

    WORKPLACE READY®

    • Single Dose
    • Tamper Evident

    Xpect® First aid

    • Relieves Sinus Headache, Sinus Pressure, Nasal Congestion, Mucus, Chest Congestion

    80 Caplets • 40 Packets per Box

    box-80

  • Principal Display Panel - 200 count box

    COLD RELIEF

    Active Ingredients:

    Acetaminophen

    Guaifenesin

    Phenyleprine HCl

    Pain Reliever/Fever Reducer

    Expectorant

    Nasal Decongestant

    WORKPLACE READY®

    • Single Dose
    • Tamper Evident

    Xpect® First aid

    • Relieves Sinus Headache, Sinus Pressure, Nasal Congestion, Mucus, Chest Congestion

    200 Caplets • 100 Packets per Box

    box-200

  • INGREDIENTS AND APPEARANCE
    XPECT COLD RELIEF 
    acetaminophen guaifenesein phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-112-1180 in 1 BOX03/29/2021
    1NDC:42961-112-102 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    2NDC:42961-112-12200 in 1 BOX12/30/2022
    2NDC:42961-112-102 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/29/2021
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    L.N.K. International832867837manufacture(42961-112)