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Xpect Cold Relief

Xpect Cold Relief

Approved
Approval ID

02391d55-32b2-4083-9315-98e9b3650c55

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

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
NDC Product Code42961-112
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen Guaifenesein Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (17)

GUAIFENESINActive
Quantity: 200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

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.

Box-40

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/30/2022

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

LOINC: 55106-9Updated: 9/23/2025

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/30/2022

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 12/30/2022

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

LOINC: 50570-1Updated: 12/30/2022

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

LOINC: 50569-3Updated: 12/30/2022

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

LOINC: 50568-5Updated: 12/30/2022

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/30/2022

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

LOINC: 51727-6Updated: 12/30/2022

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

LOINC: 42229-5Updated: 12/30/2022

When using this product do not exceed recommended dosage.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 12/30/2022

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

LOINC: 53414-9Updated: 12/30/2022

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/30/2022

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

LOINC: 34068-7Updated: 12/30/2022

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

LOINC: 53413-1Updated: 12/30/2022

Questions?

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

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Xpect Cold Relief - FDA Drug Approval Details