Label: THERAFLU COLD AND FLU- acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder

  • NDC Code(s): 0067-0924-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated May 2, 2024

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  • TheraFlu Cold and Flu

    Pharmaceutical form:Powder for oral solution (berry flavor).

  • Active Ingrédient

    paracetamol 325.0 mg

    pheniramine maleate 20.0 mg

    phenylephrine hydrochloride 10.0 mg.

  • Purpose

    • Antipyretic
    • Analgesic
    • Vasoconstrictive
    • Decongestant
    • Antiallergic
  • Indications:

    Symptomatic therapy of infectious and inflammatory disorders: acute respiratory viral infections (ARVI) including influenza and common cold associated with: high temperature, chill, headache, sore throat, rhinitis, nasal congestion, sneezing, muscle pain.

  • Dosage and administration:

    For oral administration. Dissolve one sachet in a glass of hot, but not boiling, water. Take hot.

    Take one sachet every 4 – 6 hours as required but not more than 4 doses within 24 hours. The product should not be administered for more than 5 days.

    Excipients: see patient information leaflet

  • Contraindications:

    Hypersensitivity to individual product ingredients, co-administration of tricyclic antidepressants, beta-adrenergic blockers or other sympathomimetic products, hyperthyroidism, pheochromocytoma, angle-closure glaucoma, alcoholism, pregnancy, breastfeeding, pediatric use under 12 years of age. For a complete list of contraindications, see patient information leaflet.

  • Excipients:

    sucrose, acesulfame potassium, Allura Red AC Е129 (FD&C red No.40), Brilliant Blue Е133 (FD&C No.1), maltodextrin, silicon dioxide, natural raspberry flavor WONF Durarome (860385 TD0994), natural cranberry Durarome flavor (861149 TD2590, citric acid anhydrous, sodium citrate dihydrate, calcium phosphate tribasic, magnesium stearate.

  • Storage conditions:

    At temperature not higher than 25°C.

  • Keep out of reach of children.

  • OTC medicine

  • Marketing authorisation No. ЛС-001960

  • Principal Display Panel

    NDC 0067-0924-01

    THERAFLU

    COLD & FLU

    contains paracetamol 325 mg

    • FEVER MUSCLE PAIN
    • HEADACHE RUNNYNOSE
    • SORE THROAT NASAL CONGESTION
    • CHILLS SNEEZING

    Berry flavour

    10 SACHETS

    Theraflu Cold and Flu Berry
  • INGREDIENTS AND APPEARANCE
    THERAFLU COLD AND FLU 
    acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0924
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE20 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0924-0110 in 1 CARTON; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only03/01/2022
    Labeler - Haleon US Holdings LLC (079944263)