MUCUS RELIEF COLD FLU AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [RARITAN PHARMACEUTICALS INC]

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  • MUCUS RELIEF COLD FLU AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [RARITAN PHARMACEUTICALS INC]

MUCUS RELIEF COLD FLU AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [RARITAN PHARMACEUTICALS INC]
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NDC 68163-737-09
Set ID 2cb3e17f-3858-4773-a53f-0860ae6ff1b9
Category HUMAN OTC DRUG LABEL
Packager Raritan Pharmaceuticals Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each 20 mL)

    Acetaminophen 650 mg 

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer 

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    •
    temporarily relieves these common cold and flu symptoms:
    •
    nasal congestion
    •
    sinus congestion and pressure
    •
    cough due to minor throat and bronchial irritation
    •
    minor aches and pain
    •
    sore throat
    •
    headache
    •
    temporarily reduces fever
    •
    temporarily promotes nasal and/or sinus drainage
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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 the maximum daily amount
    •
    with other drugs containing acetaminophen
    •
    3 or more alcoholic drinks daily 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.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

    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.
    •
    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 at 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)
    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosing cup provided. Do not use any other dosing device.  
    •
    dose as follows or as directed by a doctor
    •
    mL = milliliter
    •
    adults and children 12 years of age 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 8 mg
    •
    Store at room temperature
    •
    do not refrigerate.
    •
    dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    DRx CHOICE®

    Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max™ Cold, Flu & Sore Throat *

    Maximum Strength

    Mucus Relief

    Cold, Flu & Sore Throat

    Acetaminophen - Pain Reliever/Fever Reducer

    Dextromethorphan HBr • Cough Suppressant

    Guaifenesin - Expectorant

    Phenylephrine HCI 10 mg • Nasal Decongestant

    •
    Relieves Headache, Fever & Sore Throat
    •
    Controls Cough
    •
    Relieves Nasal & Chest Congestion 
    •
    Thins & Loosens Mucus

    FOR AGES 12 +

    9 FL OZ (266 mL)

    *This product is not manufactured or distributed by Reckitt Benckiser, Distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore throat.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

    ‡Maximum Strength per 4 hour dose.

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court,

    East Brunswick, NJ 08816

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributer of Maximum Strength Mucinex® Fast-Max™ Cold, Flu & Sore Throat.

    PEEL CORNER TO READ COMPELETE DRUG FACTS AND INFORMATION

  • Package Label

    Drx Choice Mucus Relief Cold Flu and Sore Throat
  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COLD FLU AND SORE THROAT  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-737
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 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)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-737-09266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/05/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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