Label: PANADOL COLD AND FLU NONDROWSY- acetaminophen and phenyleprine hcl tablet, film coated

  • NDC Code(s): 0135-0607-01, 0135-0607-02, 0135-0607-03
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 6, 2024

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  • Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever/Fever reducer

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to the common cold or flu:
      • nasal congestion
      • stuffy nose
      • sore throat
      • headache
      • sinus congestion and pressure
      • minor aches and pains
    • 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, 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 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, ask a doctor promptly.

    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 are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have

    • liver disease
    • diabetes
    • heart disease
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    When using this product do not exceed recommend dosage

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear

    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 can cause serious health problems. In case of 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

    • do not take more than directed(see overdose warning)
    • adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist or as directed by a doctor
    • do not take more than 12 caplets in 24 hours, unless directed by a doctor
    • children under 12 years of age: ask a doctor
    • swallow whole – do not crush, chew or dissolve
  • Other information

    • store below 25°C (77°F)
  • Inactive ingredients

    acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Principal Display Panel

    NDC 0135-0607-02

    Panadol ®

    COLD+FLU

    NON-DROWSY

    ACETAMINOPHEN

    Pain Reliever/Fever Reducer

    PHENYLEPHRINE HCl

    Nasal Decongestant

    NEW FORMULA AND DIRECTIONS

    24 CAPLETS

    TAMPER-EVIDENT FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.

    READ AND KEEP CARTON FOR COMPLETE INFORMATION

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2017 GSK group of companies or its licensor. All rights reserved.

    Distributed by: GSKConsumer Healthcare, Warren, NJ 07059

    30108XE

    Panadol Cold and Flu NonDrowsy 24 count carton
  • INGREDIENTS AND APPEARANCE
    PANADOL   COLD AND FLU NONDROWSY
    acetaminophen and phenyleprine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0607
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVAL (caplet) Size16mm
    FlavorVANILLAImprint Code CF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0607-0350 in 1 CARTON06/01/2017
    1NDC:0135-0607-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0135-0607-023 in 1 CARTON06/01/2017
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/01/2017
    Labeler - Haleon US Holdings LLC (079944263)
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