Label: BASIC CARE NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solution

  • NDC Code(s): 72288-601-40
  • Packager: Amazon.com Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

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

  • Active ingredients (in each 15 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine Succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    •
    nasal congestion
    •
    sinus congestion and pressure
    •
    cough due to minor throat and bronchial irritation
    •
    cough to help you sleep
    •
    minor aches and pains
    •
    headache
    •
    fever
    •
    sore throat
    •
    runny nose and sneezing
    •
    reduces swelling of nasal passages
    •
    temporarily restores freer breathing through the nose
    •
    promotes nasal and/or sinus drainage
  • Warnings

    Liver warning: This product contains acetaminophen. 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
    •
    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.
    •
    to make a child sleepy
    •
    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
    •
    high blood pressure
    •
    glaucoma
    •
    thyroid disease
    •
    diabetes
    •
    cough that occurs with too much phlegm (mucus)
    •
    trouble urinating due to an enlarged prostate gland
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    Ask a doctor or pharmacist before use if you are

    •
    taking the blood thinning drug warfarin
    •
    taking sedatives or tranquilizers

    When using this product

    •
    do not use more than directed
    •
    excitability may occur, especially in children
    •
    marked drowsiness may occur
    •
    avoid alcoholic drinks
    •
    be careful when driving a motor vehicle or operating machinery
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness

    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.

    Overdose warning: 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.

  • Directions

    •
    take only as directed – see Overdose warning
    •
    only use the dose cup provided
    •
    do not exceed 4 doses per 24 hrs
     
    adults & children 12 yrs & over
     
    30 mL every 4 hrs
     
    children 6 to under 12 yrs
     
    15 mL every 4 hrs
     
    children 4 to under 6 yrs
     
    ask a doctor
     
    children under 4 yrs
     
    do not use
  • Other information

    •
    each 15 mL contains: sodium 15 mg
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

  • Questions?

    1-800-719-9260

  • Package/Label Principal Display Panel

    amazon

    basic care

    Multi-Symptom Relief

    Compare to Vicks® NyQuil® Severe Honey Flavor active ingredients

    Nighttime Severe Cold & Flu

    Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Doxylamine Succinate

    Pain Reliever, Fever Reducer, Nasal Decongestant, Cough Suppressant, Antihistamine

    Max Strength

    Honey Flavor

    12 FL OZ (355 mL)

    nighttime severe cold and flu image
  • INGREDIENTS AND APPEARANCE
    BASIC CARE NIGHTTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-601
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-601-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/22/2022
    Labeler - Amazon.com Services LLC (128990418)