Label: FLU RELIEF THERAPY DAYTIME- acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid

  • 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 February 11, 2023

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

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to a cold
      • minor aches and pains
      • headache
      • nasal congestion
      • sore throat
      • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
  • Warnings

    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: Acetaminophen may cause severe skin reactions. Symptoms may inclide:

    • 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

    • 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. 
    • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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
    • cough that occurs with too much phlegm (mucus)
    • 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.

    When using this product,

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • nervousness,dizziness, or sleeplessness occur 
    • pain, cough, or nasal congestion get 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 a fever, 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

    • do not take more than directed (see overdose warning)
    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • mL= milliliter
    • keep dosing cup with product
    • adults and children 12 years and over
      • 30 mL every 4 hours
    • chlldren under 12 years of age: do not use 
  • Other information

    • each 30 mL contains: sodium 16 mg 
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions or comments?

    Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to TheraFlu® Daytime Severe Cold & Cough active ingredients*

    DAYTIME

    Severe Cold & Cough

    Acetaminophen Pain Reliever / Fever Reducer

    Dextromethorphan HBr Cough Suppressant

    Phenylephrine HCl Nasal Decongestant

    Flu & Severe Cold

    • Nasal Congestion
    • Fever
    • Cough
    • Sore Throat
    • Headache
    • Body Ache

    Alcohol 10%

    For Ages 12 Years & Over

    Cherry Flavor

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER  CAP IS BROKEN OR MISSING.

    *This product is not manufactured or distributed by GSK Consumer Health, Inc., distributor of Theraflu® Daytime Severe Cold & Cough

    MADE WITH PRIDE & CARE FOR H-E-B®, SAN ANTONIO, TX 78204

    Questions or comments?

    Call toll free 1-877-753-3935

    Monday-Friday 9AM-5PM EST

  • Product Label

    Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCI 10 mg

    H-E-B DayTime Severe Cold & Cough

  • INGREDIENTS AND APPEARANCE
    FLU RELIEF THERAPY  DAYTIME
    acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-016-08245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/201612/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/31/201612/31/2025
    Labeler - H E B (007924756)