PANADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

PANADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0608-01, 0135-0608-02, 0135-0608-03, 0135-0608-04
Set ID 01e7dddb-755c-4745-b701-edcdb6209064
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • 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
    be careful when driving a motor vehicle or operating 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

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

    carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-455-7139

  • Principal Display Panel

    NDC 0135-0608-01

    PANADOL

    EXTRA STRENGTH

    PM

    ACETAMNOPHEN

    Pain Reliever

    DIPHENHYDRAMINE HCl

    Nighttime Sleep-Aid

    24 CAPLETS

    Tamper-Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken.

    READ AND KEEP CARTON FOR COMPLETE INFORMATION

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

    Distributed by:

    GSK Consumer Healthcare, Warren, NJ 07059

    ©2016 GSK group of companies or its licensor.

    101639XE

    101639XE_Panadol PM_24 ct.JPG
  • INGREDIENTS AND APPEARANCE
    PANADOL  PM
    acetaminophen and diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0608
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVAL (Caplet) Size17mm
    FlavorImprint Code PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0608-011 in 1 CARTON12/01/2016
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0135-0608-021 in 1 CARTON12/01/2016
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0135-0608-0350 in 1 CARTON12/01/2016
    3NDC:0135-0608-042 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/01/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

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