Sinus Relief Headache Nasal
FDA Label NDC 52904-493

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Sinus Relief Headache Nasal (NDC 52904-493). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer
Phenylephrine HCl 5 mg.............................Nasal Decongestant



Otc - Purpose

Pain Reliever, Fever Reducer, Nasal Decongestant

Dosage & Administration

Directions: 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 : Consult a
doctor

Indications & Usage

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 free breathing. Temporarily
relieves minor aches, pains, and fever associated with:
• headache • common cold • toothache • backache • muscular
aches • menstrual cramps

Warnings

Warnings: Liver Warning: This product containsacetaminophen. Severe liver damage may occur if you take:• more than 8 tablets in 24 hours • with other drugs containingacetaminophen (prescription or nonprescription). Ask a doctoror pharmacist before using with other drugs if you are not sure.• 3 or more alcoholic drinks every day while using this productDo not: • use with any other product containingacetaminophen this will provide more than the recommendeddose (overdose) of acetaminophen and could cause serioushealth concerns. • use more than the recommended dosefor more than 10 days for pain unlessdirected by a doctor • for more than 3 days forfever unless directed by a doctor • when using thisproduct do not exceed recommended dose. • if youare now taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression,psychiatric or emotional conditions, or Parkinson'sdisease), or for 2 weeks after stopping MAOI drug. If you donot know if your prescription drug contains an MAOI, consulta doctor or pharmacist before taking this product. Stop useand ask a doctor if: • symptoms do not improve • pain or feverpersists or gets worse • new symptoms occur • redness orswelling is present • nervousness, dizziness or sleeplessnessoccur • symptoms do not improve within 7 days or areaccompanied by fever. Ask a doctor before use if you have:• heart disease • high blood pressure • thyroid disease• diabetes • difficulty in urination due to enlargement of theprostate gland

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Inactive Ingredient

Inactive Ingredients: corn starch, FDC Blue 1, maltodextrin,
microcrystalline cellulose, polyethylene glycol, povidone, sodium
starch glycolate, and stearic acid

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