Label: TUKOL DAY TIME COLD AND FLU RELIEF SOFTGELS- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

  • 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 January 10, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each softgel)
    Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    temporarily relieves common cold and flu symptoms:

    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 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 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 products 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 drugs. 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
    • thyroid disease
    • diabetes
    • high blood pressure
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough as occurs with smoking, asthma, or emphysema

    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

    • you get nervous, dizzy or sleepless
    • symptoms get worse or last 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.
    • a skin reaction occurs. 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. In case of accidental overdose, get medical help or contact a Poison Control Center 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

    • take only as directed (see Warnings)
    • do not exceed 4 doses per 24 hours
      Adults and children 12 years and over: take 2 softgels with water every 4 hours
      Children 4 to under 12 years: Ask a doctor
      Children under 4 years: Do not use
    • When using Day Time or Night Time products, carefully read each label to ensure correct dosing
  • Other information

    • store at room temperature 20-25°C (68-77°F)
  • Inactive Ingredients

    FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified Water, Sorbitol sorbitan solution, Titanium dioxide.

  • Questions or comments?

    Call toll free 1-877-994-3666

    Weekdays from 8 am to 6 pm

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA, Inc.
    Houston, TX 77098

  • PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton

    NEW
    Non Drowsy

    Tukol®

    DAY TIME
    COLD AND FLU RELIEF

    Acetaminophen / Dextromethorphan HBr /
    Phenylephrine HCl

    • COUGH
    • FEVER
    • SORE THROAT
    • ACHES
    • NASAL CONGESTION

    24 Softgels

    Principal Display Panel - 24 Softgel Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    TUKOL DAY TIME COLD AND FLU RELIEF SOFTGELS 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-312
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 604
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-312-242 in 1 CARTON01/10/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/10/2023
    Labeler - Genomma Lab USA (832323534)