Label: COLD PREPARATION FOR COUGH AND SINUS RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

  • NDC Code(s): 11868-466-08, 11868-466-12
  • Packager: New Genesis/Monticello Drug LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 5, 2016

If you are a consumer or patient please visit this version.

  • Active ingredients (in each 15 mL)

    Acetaminophen 325 mg

    Dextromethoprhan HBr 10 mg

    Phenlyephrine HCl 5 mg

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  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

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  • Uses

    • temporarily relieves these common cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • fever
      • nasal congestion
      • cough due to minor throat and bronchial irritation
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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 6 doses (180 mL) in 24 hours for adults
    • more than 5 doses ( 75 mL) in 24 hours for children 6-12 years old
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday while using this product

    Allery 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

    • 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.
    • 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.

    Ask a doctor before use if the user has

    • liver disease
    • heart disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • a sodium-restricted diet
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough accompanied by excessive phlegm (mucus)
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin.

    When using this product,

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • redness or swelling is present
    • new symptoms occur
    • nervousness, dizziness or sleeplessness occurs
    • fever gets worse or lasts more than 3 days
    • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    • 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.

    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) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take more than directed (see overdose warning)
    • do not exceed 4 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
     age  dose
     adults and children 12 years and over 30 mL every 4 hours 
     children 6 to 11 years  15 mL every 4 hours
     children 4 to under 6 years  ask a doctor
     children under 4 years  do not use
    • When using Day Time and Night Time products, carefully read each label to ensure correct dosing
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  • Other information

    • each 15 mL contains: sodium 12 mg
    • store between 20-25ºC (68-77ºF)
    • do not refrigerate
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  • Inactive ingredients

    citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

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  • Questions or comments?

    Call us at 904-647-7825 or online at www.newgenesismonticellodrug.com

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  • Principal Display Panel

    *Compare to active ingredients in Vicks® DayQuil®

    Cold Preparation

    Acetaminophen

    Pain reliever/fever reducer

    Dextromethorphan hBr

    Cough suppressant

    Phenylephrine HCl

    Nasal decongestant

    For cough and sinus relief

    For ages 6 and over

    FL OZ (mL)

    TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

    Distributed by: New Genesis/Monticello Drug LLC

    Jacksonville, FL 32207

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  • Package Label

    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

    Monticello Cold Preparation

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  • INGREDIENTS AND APPEARANCE
    COLD PREPARATION  FOR COUGH AND SINUS RELIEF
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11868-466
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11868-466-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 01/01/2022
    2 NDC:11868-466-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2015 01/01/2022
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 06/30/2015 01/01/2022
    Labeler - New Genesis/Monticello Drug LLC (079396165)
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