Label: SINUS RELIEF SEVERE CONGESTION- acetaminophen,guaifenesin, phenylephrine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 15, 2012

If you are a consumer or patient please visit this version.

  • 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)