SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]

SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]
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NDC 52904-455-02, 52904-455-06, 52904-455-50
Set ID 9196d2e1-c3ef-4b46-b10b-bbab08229cbb
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                              Purpose

    Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer
    Guaifenesin 200 mg.............................Expectorant
    Phenylephrine HCl 5 mg.............................Nasal Decongestant

  • PURPOSE

    Pain Reliever, Fever Reducer, Expectorant, Nasal Decongestant

  • DOSAGE

    Directions: Adults and children 12
    years and over: • take 2 tablets every 4 to 6 hours as needed, do
    not exceed more than 8 tablets in 24 hours,or as directed by a
    doctor Children under 12 years: • consult a doctor

  • INDICATIONS

    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
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive

    • Temporarily relieves minor aches, pains, and fever associated with:

    • headache

    • common cold

    • toothache

    • backache

    • muscular aches

    • menstrual cramps

  • 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 • A persistent cough may be a sign of a serious condition

    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. • 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 pharmacist before taking this product. • 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 the recommended dose. Ask a doctor before use if you
    have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urinating due to an enlarged
    prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where
    cough is accompanied by excessive phlegm (mucus)

    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 • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache

  • PREGNANCY

    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: FDC Red 40,
    Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch
    Glycolate, Starch, Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    MM1

    sinus relief severe packet

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF SEVERE CONGESTION  
    acetaminophen,guaifenesin, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-455
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 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 RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Colorpink (blossom pink) Scoreno score
    ShapeROUND (FR14) Size12mm
    FlavorImprint Code FR14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-455-5025 in 1 BOX10/15/2012
    1NDC:52904-455-061 in 1 CARTON
    1NDC:52904-455-022 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Labeler - Select Corporation (053805599)
    Establishment
    NameAddressID/FEIBusiness Operations
    Select Corporation053805599label(52904-455)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(52904-455)

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