SWIFT SINUS PAIN (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET SINUS PAIN (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]

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  • SWIFT SINUS PAIN (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET SINUS PAIN (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]

SWIFT SINUS PAIN (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET SINUS PAIN (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-1040-01, 0498-1040-10, 0498-1040-25, 0498-1040-50, 0498-1041-01, 0498-1041-10, 0498-1041-25, 0498-1041-50
Set ID cd167c7c-2e4a-49b9-9fec-d16c15ec77bf
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain relieve/fever reducer

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms associated with hayfever and other upper respiratory allergies
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • minor aches and pains
    • helps decongest sinus openings and passages
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur

    • if you take more than 4,00 mg acetaminophen in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If skin reaction occurs, stop use and seek medical attention right away.

    Do not use

    • with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibiter (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 use.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • diabetes
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • liver disease

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • pain or nasl congestion get worse or last more than 7 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

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

    Keep out of the reach of children.

    Overdose warning: In case of accidental overdose, getmedical help or contact a Poison Control Center right away. Promt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    • do not take morethan directed (see overdose warning)

    Adults and children 12 years of age and older: take 2 tablets every 4-6 hours while symptoms persist

    • do not exceed 8 tablets in 24 hours unless directed by a doctor

    Children under 12 years: consult a doctor

  • Other Information

    • store at room temperature 15-30C (59-86F)
    • avoid excessive heat and humidity
    • TAMPER EVIDENT PACKETS - DO NOT USE IF OPEN OR TORN
  • Inactive ingredients

    Inactive Ingredients: FD&C Blue #1, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

  • Questions or comments?

    1-800-430-5490

  • PRINCIPAL DISPLAY PANEL

    MM1 Sinus Pain Hundred Count Label

  • Sinus Pain

    Honeywell Sinus Pain

  • INGREDIENTS AND APPEARANCE
    SWIFT SINUS PAIN 
    acetaminophen, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorblue (sky blue) Scoreno score
    ShapeROUND (FR40) Size12mm
    FlavorImprint Code FR40
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-1040-25250 in 1 BOX04/14/201101/01/2017
    1NDC:0498-1040-10100 in 1 BOX
    1NDC:0498-1040-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-1040-50500 in 1 BOX; Type 0: Not a Combination Product04/14/201101/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/14/201101/01/2017
    SINUS PAIN 
    acetaminophen, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorblue (sky blue) Scoreno score
    ShapeROUND (FR40) Size12mm
    FlavorImprint Code FR40
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-1041-10100 in 1 BOX01/02/2017
    1NDC:0498-1041-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-1041-25250 in 1 BOX01/02/2017
    2NDC:0498-1041-012 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-1041-50500 in 1 BOX01/02/2017
    3NDC:0498-1041-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/02/2017
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321repack(0498-1040, 0498-1041)
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