Label: PANADOL PM- acetaminophen and diphenhydramine hcl tablet, film coated

  • NDC Code(s): 0135-7021-01, 0135-7021-02, 0135-7021-03
  • 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 500 mg

    Diphenhydramine HCl 25 mg

  • Purposes

    Pain reliever

    Nighttime sleep-aid

  • Uses

    • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
  • 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 include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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.
    • with any other product containing diphenhydramine, even one used on skin
    • in children under 12 years of age
    • 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
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking

    • the blood thinning drug warfarin
    • sedatives or tranquilizers

    When using this product

    • drowsiness will occur
    • avoid alcoholic drinks
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
    • pain gets worse or lasts more than 10 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 at bedtime, if needed, or as directed by a doctor
    • do not give to children under 12 years of age
  • Other information (2 caplets)

    • store at 25°C (77°F)
  • Other information (24 and 50 caplets)

    • store at 25°C (77°F)
    • close cap tightly after use
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions?

    1-800-455-7139

  • Additional Information (2 caplets)

    TAMPER-EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN

    Fold Back And Tear To Open Or Use Scissors

    Dist. by: GSKConsumer Healthcare,Warren, NJ 07059

    Trademarks owned or licensed by GSK.

    ©2021 GSK or licensor.

  • Additional Information ( (24 and 50 caplets)

    Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.

    READ AND KEEP CARTON FOR COMPLETE INFORMATION

    Dist. by: GSKConsumer Healthcare

    Warren, NJ 07059

    Trademarks owned or licensed by GSK.

    ©2021 GSK or licensor.

  • Principal Display Panel

    NDC 0135-7021-03

    Panadol

    EXTRA STRENGTH

    PM

    ACETAMNOPHEN

    Pain Reliever

    DIPHENHYDRAMINE HCl

    Nighttime Sleep-Aid

    50 CAPLETS

    Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.

    READ AND KEEP CARTON FOR COMPLETE INFORMATION

    Dist. by: GSKConsumer Healthcare

    Warren, NJ 07059

    Trademarks owned or licensed by GSK.

    ©2021 GSK or licensor.

    B-0630-765-08 ORG

    Panadol PM 50 ct
  • INGREDIENTS AND APPEARANCE
    PANADOL   PM
    acetaminophen and diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-7021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (Caplet) Size17mm
    FlavorImprint Code PAN;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-7021-0150 in 1 CARTON05/19/2022
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0135-7021-021 in 1 CARTON12/07/2021
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0135-7021-031 in 1 CARTON12/07/2021
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/25/2021
    Labeler - Haleon US Holdings LLC (079944263)
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