Label: BASIC CARE DAY TIME COLD AND FLU NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit

  • 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 July 29, 2019

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

  • Active ingredients (in each liquid gel) DAY Cold & Flu

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purposes DAY Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Active ingredients (in each liquid gel) NIGHT Cold & Flu

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • Purposes NIGHT Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves these common cold and flu symptoms:
    sinus congestion and pressure
    cough
    minor aches and pains
    headache
    nasal congestion
    sore throat
    runny nose (NIGHT only)
    sneezing (NIGHT only)
    itching of the nose or throat (NIGHT only)
    itchy, watery eyes due to hay fever (NIGHT only)
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
    controls cough to help you get to sleep
    temporarily reduces fever
  • Warnings

    Liver warning: These products contain 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 these products

    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 these products.
    if you have ever had an allergic reaction to these products or any of their ingredients

    Ask a doctor before use if you have

    liver disease
    heart disease
    diabetes
    high blood pressure
    thyroid disease
    trouble urinating due to an enlarged prostate gland
    glaucoma (NIGHT only)
    a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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
    taking sedatives or tranquilizers (NIGHT only)

    When using these products

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

    Stop use and ask a doctor if

    nervousness, dizziness, or sleeplessness occur
    pain, nasal congestion or cough gets worse or lasts more than 7 days
    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

    do not take more than directed (see Overdose warning)
    do not take more than 10 liquid gels in any 24-hour period
    adults and children 12 years of age and older: take 2 liquid gels every 4 hours
    children under 12 years of age: do not use
  • Other information

    store at 20-25°C (68-77°F)
  • Inactive ingredients (DAY only)

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

    *may contain this ingredient

  • Inactive ingredients (NIGHT only)

    D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Mucinex® Fast-Max® Day Cold & Flu & Night Cold & Flu active ingredients

    Maximum Strength

    Fast Dissolving Liquid Gels

    For Ages 12+

    daytime cold & flu

    Acetaminophen

    Dextromethorphan HBr

    Guaifenesin

    Phenylephrine HCl

    Pain Reliever/Fever Reducer

    Cough Suppressant

    Expectorant

    Nasal Decongestant

    All in One Relief

    Sore Throat, Fever, Chest Congestion, Cough, Nasal Congestion, Sinus Congestion, Sinus Pressure, Headache, Body Pain

    actual size

    16 LIQUID GELS (Liquid Filled Capsules)

    For Ages 12+

    night time cold & flu

    Acetaminophen

    Dextromethorphan HBr

    Doxylamine Succinate

    Phenylephrine HCl

    Pain Reliever/Fever Reducer

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

    All in One Relief

    Sore Throat, Fever, Itchy Throat, Cough, Nasal Congestion, Sneezing, Runny Nose, Headache, Body Pain

    actual size

    8 LIQUID GELS (Liquid Filled Capsules)

    day time night time cold and flu image 1
    day time night time cold and flu image 2
  • INGREDIENTS AND APPEARANCE
    BASIC CARE DAY TIME COLD AND FLU NIGHT TIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-7581
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-7581-901 in 1 KIT; Type 0: Not a Combination Product07/29/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 BLISTER PACK 16 
    Part 24 BLISTER PACK
    Part 1 of 2
    BASIC CARE DAY TIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize25mm
    FlavorImprint Code 7G0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Part 2 of 2
    BASIC CARE NIGHT TIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 345
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/29/2019
    Labeler - L. Perrigo Company (006013346)