MUCUS RELIEF SEVERE COLD DAYTIME MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TARGET CORPORATION]

MUCUS RELIEF SEVERE COLD DAYTIME MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TARGET CORPORATION]
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NDC 11673-410-06
Set ID 5ccaf3b0-096a-4644-9c6e-9f251c167b3c
Category HUMAN OTC DRUG LABEL
Packager TARGET Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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 

    Antihistamine/Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • cough
      • nasal congestion
      • minor aches and pains
      • sore throat
      • headache
    • temporarily reduces fever
    • 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 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.

    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
    • diabetes
    • thyroid disease
    • high blood pressure
    • 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

    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 fever, 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.

    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 (1-800-222-1222) 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 any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • dose as follows or as directed by a doctor
    • adults and children 12 years and older: 20 mL every 4 hours
    • children under 12 years of age: do not use

  • Other information

    • each 20 mL contains: sodium 12 mg
    • store between 20-25ºC (68-77º). Do not refrigerate.
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-800-910-6874

  • Principal Display Panel

    Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® DayTime Severe Cold*

    Maximum Strength

    daytime severe cold

    Acetaminophen

    (pain reliever / fever reducer)

    dextromethorphan HBr (cough Suppressant)

    guaifenesin (expectorant)

    phenylephrine HCl (nasal decongestant)

    relieves aches, fever and sore throat controls cough

    relieves nasal and chest congestion thins and loosen mucus

    AGES 12 + YEARS

    FL OZ (mL)

    *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DayTime Severe Cold.

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

    Dist. by Target Corp.

    Mpls., MN 55403

    Product of U.S.A.

  • Package Label

    Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCI 10 mg

    TARGET Maximum Strength DayTime severe Cold

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF SEVERE COLD  DAYTIME MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-410
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    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)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-410-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/31/2016
    Labeler - TARGET Corporation (006961700)

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