SINUS CONGESTION AND PAIN NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [FRED'S, INC.]

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SINUS CONGESTION AND PAIN NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [FRED'S, INC.]
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NDC 55315-558-08
Set ID 5ce081f7-5f8b-4534-a998-622d7d032d5b
Category HUMAN OTC DRUG LABEL
Packager FRED'S, INC.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each gelcap)

    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 respiratory allergies, and the common cold:
      • headache
      • nasal congestion
      • sinus congestion and pressure
      • 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 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 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

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

    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 of 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
    • adults and children 12 years and over
      • take 2 gelcaps every 4 hours
      • do not take more than 10 gelcaps in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    fred's®
    Pharmacy

    NDC 55315-558-08

    Daytime Non-Drowsy

    SINUS
    CONGESTION & PAIN
    Acetaminophen     - Pain Reliever/Fever Reducer
    Phenylephrine HCl - Nasal Decongestant

    • Headache
    • Nasal Congestion
    • Sinus Congestion & Pressure

    24 RAPID RELEASE
    GELCAPS

    Compare to the active ingredients in:
    Tylenol® SINUS +
    HEADACHE Day*

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® SINUS + HEADACHE Day.
    50844      REV0216C55808

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD, MEMPHIS, TN 38118
    www.fredsinc.com

    100% satisfaction
              guaranteed
    Questions or comments: 1-855-331-FRED (3733)

    Freds 44-558

    Freds 44-558

  • INGREDIENTS AND APPEARANCE
    SINUS CONGESTION AND PAIN  NON-DROWSY
    acetaminophen and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-558
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorRED, GREENScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L;8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-558-082 in 1 CARTON03/17/200803/14/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/17/200803/14/2022
    Labeler - FRED'S, INC. (005866116)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(55315-558)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(55315-558)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(55315-558)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(55315-558)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(55315-558)
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