Xpect Cold Relief
Xpect Cold Relief
02391d55-32b2-4083-9315-98e9b3650c55
HUMAN OTC DRUG LABEL
Sep 23, 2025
Cintas Corporation
DUNS: 056481716
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen Guaifenesein Phenylephrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (17)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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.
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Expectorant
Nasal decongestant
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
OTHER SAFETY 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 INGREDIENT SECTION
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
SPL UNCLASSIFIED SECTION
When using this product do not exceed recommended dosage.
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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
OTC - QUESTIONS SECTION
Questions?
1-877-973-2811 Monday-Friday 8:00 AM-5:00 PM