SINUS RELIEF HEADACHE NASAL (ACETAMINOPHEN,PHENYLEPHRINE HCL ) TABLET [SELECT CORPORATION]

SINUS RELIEF HEADACHE NASAL (ACETAMINOPHEN,PHENYLEPHRINE HCL ) TABLET [SELECT CORPORATION]
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NDC 52904-493-02
Set ID 1d975dea-6135-4560-b62e-fa31109fd002
Category HUMAN OTC DRUG LABEL
Packager Select Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients

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



  • 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 contains
    acetaminophen. Severe liver damage may occur if you take:
    • more than 8 tablets in 24 hours • with other drugs containing
    acetaminophen (prescription or nonprescription). Ask a doctor
    or pharmacist before using with other drugs if you are not sure.
    • 3 or more alcoholic drinks every day while using this product
    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. • use 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 • when using this
    product do not exceed recommended dose. • 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 product. 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 • high blood pressure • thyroid disease
    • diabetes • difficulty in urination due to enlargement of the
    prostate gland
  • PREGNANCY OR BREAST FEEDING

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

  • 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

  • PRINCIPAL DISPLAY PANEL

    MM1

    Sinus Relief Headache nasal

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF HEADACHE NASAL  
    acetaminophen,phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-493
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (sky blue) Scoreno score
    ShapeROUND (FR2) Size11mm
    FlavorImprint Code FR2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-493-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Labeler - Select Corporation (053805599)

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