TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]

TUSSNEX FM COLD AND SINUS (ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]
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NDC 53041-616-58
Set ID 04c6bb6a-d2f8-4322-afba-e240e8090176
Category HUMAN OTC DRUG LABEL
Packager Guardian Drug Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each 20 mL)

    Acetaminophen 650 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purpose

    Pain reliever/fever reducer

    Expectorant

    Nasal decongestant

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • Warnings

    • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
    • more than 6 doses in 24 hours, which is maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product
    • Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for children under 12 years of age
    • 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.

    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
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin

    When using this product
    • do not use more than directed

    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 persistent headache. 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. 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)
    • do not take more than 6 doses in any 24 hour period
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours.
    • Children under 12 years of age: Do not use
  • Other information

    • each 20 mL contains: sodium 20 mg
    • store between 15-30oC(59-86oF)
    • do not refrigerate
    • dosing cup provided
  • Inactive ingredients

    citric acid anhydrous, edetate disodium, FD and C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

  • PDP

    Compare to the active ingredients in Mucinex Fast Max Cold and Sinus

    Maxumum Strength Tussnex FM

    Cold and Sinus

    Acetaminophen

    Pain reliever/Fever reducer

    Guaifenesin

    Expectorant

    Phenylephrine HCl

    Nasal Decongestant

    Multi-symptom

    Relieves Pain and Reduces Fever

    Relieves Nasal and chest congestion

    Thins and loosens mucus

    For ages 12 and overSN

    NM

  • INGREDIENTS AND APPEARANCE
    TUSSNEX FM COLD AND SINUS 
    acteaminophen, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-616
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-616-58177 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2012
    Labeler - Guardian Drug Company (119210276)

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