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  5. Label Information: Sinus Relief Headache Nasal

FDA Label for Sinus Relief Headache Nasal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. DOSAGE & ADMINISTRATION
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sinus Relief Headache Nasal Product Label

The following document was submitted to the FDA by the labeler of this product Select Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Package Label.Principal Display Panel



MM1


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