Label: DAY TIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 

  • Label RSS
  • NDC Code(s): 0904-5763-12, 0904-5763-44
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/13

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

  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

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  • Uses

    • temporarily relieves common cold and flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • fever
      • 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 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day 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, 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.
    • 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
    • diabetes
    • heart disease
    • thyroid disease
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, 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 exceed recommended dosage.

    Stop use and ask a doctor if

    • pain, cough, or nasal congestion gets worse or lasts more than 7 days
    • new symptoms occur
    • nervousness, dizziness or sleeplessness occur 
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • 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 can 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.

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  • Directions

    • do not take more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • adults and children 12 years and over: take 2 softgels with water every 4 hours
    • swallow whole; do not crush, chew, or dissolve
    • children under 12 years: do not use
    • when using other Day Time or Night Time products, carefully read each label to ensure correct dosing
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  • Other information

    • store at room temperature 15º-30ºC (59º-86ºF)
    • avoid excessive heat
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  • Inactive ingredients

    butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

    *may contain this ingredient

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  • Questions or comments?

    1-800-616-2471

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  • Principal Display Panel

    Day Time

    MULTI-SYMPTOM COLD/FLU RELIEF

    ACETAMINOPHEN - ACHES/FEVER/SORE THROAT

    DEXTROMETHORPHAN HBr - COUGH

    PHENYLEPHRINE HCl - NASAL CONGESTION

    ALCOHOL-FREE • ANTIHISTAMINE-FREE

    NON- DROWSY

    Softgels

    †Compare to the active ingredients in Vicks® DayQuil® LiquiCaps®

    †This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® LiquiCaps®.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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  • Product Label

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

    Major Day Time Cold/Flu Relief Softgel

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  • INGREDIENTS AND APPEARANCE
    DAY TIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-5763
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE  
    BUTYLATED HYDROXYTOLUENE  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    PROPYLENE GLYCOL  
    WATER  
    SORBITAN  
    SORBITOL  
    Product Characteristics
    Color ORANGE Score no score
    Shape CAPSULE Size 20mm
    Flavor Imprint Code P19;95A;36A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5763-12 12 in 1 BLISTER PACK
    2 NDC:0904-5763-44 16 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/25/2011
    Labeler - Major Pharmaceuticals (191427277)
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