Label: DAY TIME- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

  • NDC Code(s): 30142-656-38, 30142-656-40
  • Packager: Kroger Company
  • 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 11/13

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

  • Active ingredients (in each 15 mL tablespoon)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

    Close
  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    Close
  • Uses

    temporarily relieves common cold/flu symptoms:

    nasal congestion
    cough due to minor throat and bronchial irritation
    sore throat
    headache
    minor aches and pains
    fever
    Close
  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. Severe liver damage may occur if

    adult takes more than 4,000 mg of acetaminophen in 24 hours
    child takes more than 5 doses in 24 hours, which is the maximum daily amount
    taken with other drugs containing acetaminophen
    adult has 3 or more alcoholic drinks every day while using this product

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is 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.
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    liver disease
    heart disease
    thyroid disease
    diabetes
    high blood pressure
    trouble urinating due to an enlarged prostate gland
    cough that occurs with too much phlegm (mucus)
    persistent or chronic cough as occurs with smoking, asthma, or emphysema

    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

    you get nervous, dizzy or sleepless
    pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    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 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.

    In case of overdose, get medical help or contact a Poison Control Center right away. (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.

    Close
  • Directions

    take only as directed – see Liver warning
    use dose cup
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL (2 TBSP) every 4 hrs

    children 6 to under 12 yrs

    15 mL (1 TBSP) every 4 hrs

    children 4 to under 6 yrs

    ask a doctor

    children under 4 yrs

    do not use

    when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
    Close
  • Other information

    each tablespoon contains: sodium 7 mg
    store at 20°-25°C (68°-77°F)
    Close
  • Inactive ingredients

    butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

    Close
  • Questions or comments?

    1-800-632-6900

    Close
  • Principal Display Panel

    COMPARE TO active ingredients of VICKS® DAYQUIL®

    See back panel

    ALCOHOL & ANTIHISTAMINE FREE

    Multi-Symptom Relief

    Non-Drowsy

    Cold & Flu

    DayTime

    Pain Reliever/Fever Reducer - Acetaminophen

    Cough Suppressant - Dextromethorphan HBr

    Nasal Decongestant - Phenylephrine HCl

    Aches/Fever

    Cough

    Nasal Congestion

    Original Flavor

    12 FL OZ (354 mL)

    Kroger DayTime
    Close
  • INGREDIENTS AND APPEARANCE
    DAY TIME 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-656
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE  
    EDETATE DISODIUM  
    FD&C YELLOW NO. 6  
    GLYCERIN  
    SODIUM PHOSPHATE, MONOBASIC  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM  
    SUCROSE  
    XANTHAN GUM  
    MENTHOL  
    Product Characteristics
    Color ORANGE (clear) Score     
    Shape Size
    Flavor MENTHOL (with fruit) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-656-38 295 mL in 1 BOTTLE
    2 NDC:30142-656-40 354 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/11/2006
    Labeler - Kroger Company (006999528)
    Close