Label: COLD AND FLU NIGHTTIME SEVERE, 24-7 LIFE- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated

  • NDC Code(s): 66715-6516-8
  • Packager: Lil' Drug Store products, Inc.
  • 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 September 20, 2023

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

  • Drug Facts

    Drug Facts

  • Active Ingredients

    Active Ingredients (in each caplet)
    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine HCl 5 mg

  • Purpose

    ​Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine
    Nasal decongestant

  • Uses

    Uses

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

    ​Warnings

    Liver warning

    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

    Allergy alert

    Allergy alert: Acetaminophen may cause severe skin reactions.
    Symptoms may include:

    • blisters
    • rash
    • skin reddening

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning

    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

    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

    Ask a doctor before use if you have

    • liver disease
    • diabetes
    • thyroid disease
    • heart disease
    • glaucoma
    • high blood pressure
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem or chronic cough that lasts or 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

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic beverages
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor

    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 presen
    • 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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Directions

    • do not take more than directed
    • do not take more than 8 caplets in 24 hours
    • adults and children 12 years and over: take 2 caplets with water every 4 hours
    • children under 12 years: ask a doctor
  • Other information

    Other information

    • each caplet contains: sodium 3 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    Inactive ingredients

    black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    Questions or comments? 1-877-507-6516

  • Cold & Flu Nighttime Severe, 16ct, 24/7 Life - PDP/Package

    [24/7 Life logo]

    Cold & Flu
    Nighttime Severe

    Acetaminophen / Pain Reliever/Fever Reducer
    Dextromethorphan HBr /Cough Suppressant
    Doxylamine Succinate / Antihistamine
    Phenylephrine HCl / Nasal Decongestant

    Relieves: Headache, Fever, Sore Throat,
    Minor Aches & Pains, Nasal Congestion,
    Sinus Pressure, Sneezing, Runny Nose,
    Cough

    compare to Vicks ® NyQuil ®
    VapoCOOL™ SEVERE Cold &
    Flu + Congestion
    active ingredients*

    16

    CAPLETS

    Actual Size [caplet image]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU NIGHTTIME SEVERE, 24-7 LIFE 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6516
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;677
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6516-82 in 1 CARTON04/19/2022
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01204/19/2022
    Labeler - Lil' Drug Store products, Inc. (093103646)