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

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SINUS CONGESTION AND PAIN NON DROWSY (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.]
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NDC 55315-527-08
Set ID a9a36ef0-70b0-4934-94c2-399a03269823
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 caplet)

    Acetaminophen 325 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
      • headache
      • nasal congestion
      • minor aches and pains
      • sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 
    • 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:

    • blisters
    • rash
    • skin reddening

    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

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • heart disease
    • thyroid disease
    • diabetes
    • liver disease
    • high blood pressure
    • difficulty in urination due to enlargement of the 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, nasal congestion, or cough 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
    • cough comes back or occurs with rash or headache that lasts. 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 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
  • 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)
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

  • Principal Display Panel

    fred's
    Pharmacy

    NDC 55315-527-08

    Compare to the active ingredients in:
    Tylenol® SINUS SEVERE*

    Daytime Non-Drowsy
    SINUS
    CONGESTION & PAIN
    SEVERE

    Acetaminophen, Guaifenesin, Phenylephrine HCl
    Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant

    • Sinus Headache   
    • Nasal Congestion
    • Sinus Pressure      
    • Mucus & Chest Congestion

    Actual Size

    24 COATED CAPLETS

    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 Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS SEVERE.
    50844      REV0917H52708

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

    100% satisfaction guaranteed

    Freds 44-527C

    Freds 44-527C

  • INGREDIENTS AND APPEARANCE
    SINUS CONGESTION AND PAIN  NON DROWSY
    acetaminophen, guaifenesin and phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-527
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize19mm
    FlavorMINTImprint Code 44;527
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-527-082 in 1 CARTON08/06/200504/08/2022
    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 FINALpart34108/06/200504/08/2022
    Labeler - FRED'S, INC. (005866116)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(55315-527)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(55315-527)
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