Xpect Sinus Relief

Manufacturer
Cintas Corporation
Effective date
2021-03-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:48:20

Label at a glance#

ProductXpect Sinus Relief
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Active ingredients (in each tablet)
Acetaminophen 325mg…………….. Internal Analgesic
Phenylephrine HCl 5mg……………Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves:
• Sinus pain
• Headache
• Nasal and sinus congestion
• Minor aches and pains

Warnings

WARNINGS SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• More than 8 tablets in 24 hours, which is the maximum daily amount
• 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:
• Skin reddening
• Blisters
• Rash
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use:
• 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 pharmacists before using this product.
• For more than 3 days for fever unless directed by a doctor
• With any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• For more than 10 days for pain unless directed by a 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
Ask a doctor before use if you are taking the blood thinning drug warfarin.
When using this product do not exceed recommended dose
Stop use and ask doctor if:
• New symptoms occur
• Redness or swelling is present
• Pain gets worse or lasts for more than 10 days
• Fever gets worse or lasts more than 3 days
• Nervousness, dizziness, or sleeplessness occurs
• If cold gets worse or lasts more than 7 days
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not exceed 8 tablets in 24 hours, or as directed by a doctor.
• Children under 12 years: Do not use this product; This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

Other Information

OTHER SAFETY INFORMATION

Do not use if packet is torn, cut or opened
• Store at room temperature
• Avoid excessive heat and humidity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg
Phenylephrine HCl 5mg

INACTIVE INGREDIENT SECTION

FD&C Blue #1, Hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sinus ReliefSinus Relief

Products#

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DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-20642961-206-01, 42961-206-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
851faaa4-db63-476e-82c2-39f0a873051ec4e0962d-b539-47bb-bfdc-11ad7b079cf12022-12-31WarningsExact identifier
spl set id: c4e0962d-b539-47bb-bfdc-11ad7b079cf1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.