Label: MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU- acetaminophe, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl tablets kit

  • NDC Code(s): 49483-726-64
  • Packager: TIME CAP LABORATORIES,INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 18, 2023

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)
    Day Cold & Flu

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg


    Active ingredients (in each caplet)
    Night Severe Cold & Flu

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg
    Triprolidine HCl 1.25 mg

  • PURPOSE

    Purposes
    Day Cold & Flu

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant


    Purposes
    Night Severe Cold & Flu

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant
    Antihistamine

  • INDICATIONS & USAGE

    Uses
    Day Cold & Flu

    • temporarily relieves these common cold and flu symptoms:
    o cough
    o nasal congestion
    o minor aches and pains
    o sore throat
    o headache
    o stuffy nose
    o sinus congestion and pressure
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


    Night Severe Cold & Flu
    • temporarily relieves these common cold and flu symptoms:
    o cough
    o nasal congestion
    o minor aches and pains
    o sore throat
    o headache
    o sneezing
    o sinus congestion and pressure
    o runny nose
    o itching of the nose or throat
    o itchy, watery eyes due to hay fever
    • temporarily reduces fever
    • controls cough to help you get to sleep

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if you take:
    • more than 4,000 mg in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily 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

    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 DOCTOR

    Ask a doctor before use if you have
    • liver disease
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • glaucoma (Night Severe Cold & Flu only)
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis (Night Severe Cold & Flu only)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Night Severe Cold & Flu only)

  • WHEN USING

    When using this product
    • do not use more than directed

    • excitability may occur, especially in children (Night Severe Cold & Flu only)
    • marked drowsiness may occur (Night Severe Cold & Flu only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only)
    • avoid alcoholic drinks (Night Severe Cold & Flu only)
    • use caution when driving a motor vehicle or operating machinery (Night Severe Cold & Flu only)

  • STOP USE

    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 fever, rash, or headache that lasts. These could be signs of a serious condition.
  • PREGNANCY 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.

  • OVERDOSAGE

    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 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Day Cold & Flu
    do not take more than directed (see Overdose warning)
    • do not take more than 12 caplets in any 24-hour period
    • adults and children 12 years of age and over: take 2 caplets every 4 hours
    • children under 12 years of age: do not use
    Night Severe Cold & Flu
    • do not take more than directed (see Overdose warning)

    • do not take more than 8 caplets in any 24-hour period
    • adults and children 12 years of age and over: take 2 caplets every 4 hours
    • children under 12 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other information

    • store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients Day Cold & Flu
    colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

    Inactive ingredients Night Severe Cold & Flu
    colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide

  • QUESTIONS

    Questions or Comments?

    Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    49483-726_Timely 40ct_IFC

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU 
    acetaminophe, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl tablets kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-726
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-726-644 in 1 CARTON09/21/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK 24   in 4 
    Part 24 BLISTER PACK 16   in 4 
    Part 1 of 2
    MAXIMUM STRENGTH DAY COLD AND FLU 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablets tablet
    Product Information
    Item Code (Source)NDC:49483-733
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    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
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorred (Light red to red) Scoreno score
    ShapeCAPSULE (Capsule shaped tablet) Size19mm
    FlavorImprint Code D1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/21/2023
    Part 2 of 2
    MAXIMUM STRENGTH NIGHT SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl tablets tablet
    Product Information
    Item Code (Source)NDC:49483-734
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Coloryellow (Light golden yellow to Golden yellow) Scoreno score
    ShapeCAPSULE (Capsule shaped tablet) Size19mm
    FlavorImprint Code N1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/21/2023
    Labeler - TIME CAP LABORATORIES,INC (037052099)
    Registrant - TIME CAP LABORATORIES,INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(49483-726)