Xpect Cold Relief

Xpect Cold Relief
SPL v10
SPL
SPL Set ID 02391d55-32b2-4083-9315-98e9b3650c55
Route
ORAL
Published
Effective Date 2026-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Crospovidone Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone Silicon Dioxide Sodium Starch Glycolate Type A Stearic Acid Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-03-29 Until 2025-09-23

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Expectorant Nasal decongestant

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

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
Section 50565-1

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. 

Section 53414-9

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

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. 

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
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
purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Questions? 

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

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

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.
Principal Display 40 Packets

*compare to the active ingredients in Tylenol® SINUS SEVERE

COLD RELIEF 

Active Ingredients: 

Acetaminophen

Guaifenesin

Phenylephrine HCl

Pain Reliever/Fever Reducer

Expectorant

Nasal Decongestant 

Xpect® First aid

WORKPLACE READY®

  • Single Dose
  • Tamper Evident 
  • Relieves sinus headache, sinus pressure, nasal congestion, mucus, chest congestion

80 Tablets • 40 Packets (2 tablets in each packet) per box

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS SEVERE.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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.


Structured Label Content

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
Section 50565-1 (50565-1)

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. 

Section 53414-9 (53414-9)

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

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. 

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
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
purpose (Purpose)

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Questions? 

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

Other Information (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 (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

Stop Use and Ask A Doctor If (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.
Principal Display 40 Packets (Principal Display - 40 Packets)

*compare to the active ingredients in Tylenol® SINUS SEVERE

COLD RELIEF 

Active Ingredients: 

Acetaminophen

Guaifenesin

Phenylephrine HCl

Pain Reliever/Fever Reducer

Expectorant

Nasal Decongestant 

Xpect® First aid

WORKPLACE READY®

  • Single Dose
  • Tamper Evident 
  • Relieves sinus headache, sinus pressure, nasal congestion, mucus, chest congestion

80 Tablets • 40 Packets (2 tablets in each packet) per box

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS SEVERE.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (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 (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.)


Advanced Ingredient Data


Raw Label Data

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