PAIN AND SINUS RELIEVER

Manufacturer
ADVANCED FIRST AID, INC. | ULTRA SEAL CORPORATION | ULTRA TAB LABORATORIES, INC.
Effective date
2023-01-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:41:25

Label at a glance#

ProductPAIN AND SINUS RELIEVER
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

pain reliever/fever reducer

decongestant

INDICATIONS & USAGE SECTION

Uses: temporarily: • relieves nasal congestion associated with sinusitis • relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure, helps decongest sinus openings and passages • restores freer breathing

temporarily relieves minor aches, pains, and fever associated with: • headache • common cold • toothache • backache • muscular aches • menstrual cramps

WARNINGS SECTION

Warnings:

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 • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product

Alergy 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:

• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

• more than the recommended dose

• for more than 10 days for pain unless directed by a doctor

• for more than 3 days for fever unless directed by a doctor

• 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this prouct.

Ask a doctor or pharmacist before use if: • you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if:

• symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you have: • heart disease • liver disease •high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

When using this product do not exceed recommended dose.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. 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.

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets  in 24 hours, or as directed by a doctor.

Children under 12 years: Consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: FD&C Blue #1, microcrystalline cellulose, povidone, sodium starch glycolate, starch, and stearic acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain and Sinus Reliever 100ctPain and Sinus Reliever 100ctPain and Sinus Reliever 250ctPain and Sinus Reliever 250ct

Products#

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DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67060-19467060-194-68, 67060-194-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
f1b2a5df-5742-96d5-e053-2a95a90af52397c99b40-bcd9-710b-e053-2a95a90a10a72023-01-07WarningsExact identifier
spl id: f1b2a5df-5742-96d5-e053-2a95a90af523
spl set id: 97c99b40-bcd9-710b-e053-2a95a90a10a7

Reported adverse events (FAERS/openFDA)#

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