Label: DAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid

  • NDC Code(s): 66715-6931-4
  • Packager: Lil' Drug Store Products, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 15 mL)Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • 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
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if:

    • adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
    • child takes more than 4 doses (15 mL each) in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 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.
    • 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
    • a sodium-restricted diet
    • 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

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult)
    • 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.

    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 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
    adults and children 12 years and over30 mL every 4 hours
    children 6 to under 12 years15 mL every 4 hours
    children 4 to under 6 yearsask a doctor
    children under 4 yearsdo not use
    • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
  • Other information

    • each 15 mL contains: sodium 12 mg
    • store between 20-25°C (68-77°F). Do not refrigerate.
  • 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

  • Questions or comments?

    Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    [Quality Guaranteed caduceus]

    Compare to the Active Ingredients in Vicks ® DayQuil ®

    Original

    Cold & Flu

    Daytime

    Acetaminophen, Pain Reliever/Fever Reducer

    Phenylephrine HCl, Nasal Decongestant

    Dextromethorphan HBr, Cough Supressant

    Relieves

    • Aches • Sore Throat • Fever

    • Nasal Congestion • Cough

    8 FL OZ

    (237 mL)

    [Lil' Drug Store logo]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND FLU  LIL DRUG STORE PRODUCTS
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6931
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6931-4237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)