GOOD SENSE SINUS PLUS HEADACHE (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY]

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GOOD SENSE SINUS PLUS HEADACHE (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY]
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NDC 0113-0066-62
Set ID e5540732-19e4-4895-a8ca-d87b75c37f6c
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Nasal decongestant

  • Uses

    •
    temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
    •
    headache
    •
    sinus congestion and pressure
    •
    nasal congestion
    •
    minor aches and pains
    •
    helps decongest sinus openings and passages
    •
    promotes sinus drainage
    •
    helps clear nasal passages
    •
    temporarily reduces fever
  • Warnings

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

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    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 a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    •
    with any other drug 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 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.
    •
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    •
    liver disease
    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if

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

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not take more than directed (see overdose warning)

    adults and children 12 years and over
    •
    take 2 caplets every 4 hours
    •
    swallow whole – do not crush, chew or dissolve
    •
    do not take more than 10 caplets in 24 hours

    children under 12 years

    ask a doctor
  • Inactive ingredients

    acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    For Adults

    Non-Drowsy

    Daytime

    Sinus + Headache

    Pain Reliever-Fever Reducer/Acetaminophen

    Nasal Decongestant/Phenylephrine HCl

    Actual Size

    Sinus Pressure Headache-Nasal Congestion

    Sinus Pressure

    Compare to active ingredients of Tylenol® Sinus + Headache

    100% SATISFACTION GUARANTEED

    24 Caplets

    Sinus + Headache image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE SINUS PLUS HEADACHE 
    acetaminophen, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0066
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize16mm
    FlavorVANILLA (menthol) Imprint Code L272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0066-6212 in 1 CARTON04/21/2017
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/21/2017
    Labeler - L. Perrigo Company (006013346)
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