EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE) KIT [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US)

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  • EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE) KIT [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US)

EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE) KIT [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US)
PDF | XML
NDC 0067-2056-24, 0067-8139-02, 0067-8147-01
Set ID 978a9d27-6d41-42cb-a193-11314923d2ac
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART343
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  • Excedrin PM Headache

  • Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID*)

    Diphenhydramine citrate 38 mg

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain Reliever

    Pain Reliever

    Nighttime sleep-aid

  • Uses

    •
    for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    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.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    •
    hives
    •
    facial swelling
    •
    asthma (wheezing)
    •
    shock

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    •
    more than 2 caplets 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

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    •
    are age 60 or older
    •
    have had stomach ulcers or bleeding problems
    •
    take a blood thinning (anticoagulant) or steroid drug
    •
    take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    •
    have 3 or more alcoholic drinks every day while using this product
    •
    take more or for a longer time than directed

    Do not use

    •
    if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
    •
    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

    Ask a doctor before use if

    •
    you have liver disease
    •
    stomach bleeding warning applies to you
    •
    you have a history of stomach problems, such as heartburn
    •
    you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    •
    you are taking a diuretic
    •
    you have asthma
    •
    you have glaucoma
    •
    you have a breathing problem such as emphysema or chronic bronchitis
    •
    you have trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking

    •
    a prescription drug for:
    •
    diabetes
    •
    gout
    •
    arthritis
    •
    any other drug, or are under a doctor’s care for any serious condition
    •
    any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
    •
    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

    •
    an allergic reaction occurs. Seek medical help right away.
    •
    you experience any of the following signs of stomach bleeding:
    •
    feel faint
    •
    vomit blood
    •
    have bloody or black stools
    •
    have stomach pain that does not get better
    •
    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
    •
    pain gets worse or last for more than 10 days
    •
    painful area is red or swollen
    •
    ringing in the ears or a loss of hearing occurs
    •
    any new symptoms occur

    These could be signs of a serious condition

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    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 use more than directed
    •
    do not use in children under 12 years of age
    •
    adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water
    •
    do not take more than 2 caplets in 24 hours, unless directed by a doctor
  • Other information

    •
    store at 20°-25°C (68°-77°F).
    •
    close cap tightly after use.
    •
    read all product information before using. Keep this box for important information.
  • Inactive ingredients

    benzoic acid, calcium carbonate, FD&C blue#1 aluminum lake, hydroxypropyl cellulose low substituted, hypromellose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

  • Questions or comments?

    1-800-452-0051

  • Excedrin Tension Headache

  • Active Ingredients (in each caplet)

    Acetaminophen 500 mg

    Caffeine 65 mg

  • Purposes

    Pain reliever

    Pain reliever aid

  • Uses

    •
    temporarily relieves minor aches and pain due to:
    •
    headache

    muscular aches

  • Warnings

    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.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    •
    more than 6 caplets 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

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat

    Do not use

    •
    if you are allergic to acetaminophen
    •
    with any other drug containing acetaminophen (prescription or nonprescription). 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

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    •
    any new symptoms occur
    •
    painful area is red or swollen
    •
    pain gets worse or lasts for more than 10 days
    •
    fever gets worse or lasts for more than 3 days

    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.

    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 use more than directed
    •
    adults and children 12 years and over; take 2 caplets every 6 hours; not more than 6 caplets in 24 hours

    children under 12 years: ask a doctor

  • Other information

    •
    store at 20°-25°C (68°-77°F)
    •
    close cap tightly after use

    read all product information before using. Keep this box for important information.

  • Inactive Ingredients

    benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-452-0051

  • Principal Display Panel (Excedrin PM Headache)

    DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.

    NDC 0067-2056-24

    EXCEDRIN®

    PM HEADACHE

    Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate

    Pain Reliever/Nighttime Sleep-Aid

    Triple Action Formula

    Caffeine-Free

    Non-Habit Forming

    24 CAPLETS

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

    Distributed by: GSK Consumer Healthcare

    Warren, NJ 07059

    ©2015 GSK or its licensor.

    Visit us at www.excedrin.com

    46172695

    Excedrin PM 24 count carton
  • Principal Display Panel (Excedrin Tension Headache)

    NDC 0067-8139-02

    EXCEDRIN®

    TENSION HEADACHE

    Acetaminophen and Caffeine

    Pain Reliever / Pain Reliever Aid

    Aspirin Free

    100 CAPLETS

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

    Distributed by: GSK Consumer Healthcare,

    Warren, NJ 07059

    ©2016 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies

    Visit us at www.excedrin.com

    46177300

    46177300_Excedrin Tension Headache_100 ct.JPG
  • INGREDIENTS AND APPEARANCE
    EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE 
    acetaminophen, aspirin (nsaid), caffeine, and diphenhydramine citrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8147
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8147-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product06/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 24 
    Part 21 BOTTLE 100 
    Part 1 of 2
    EXCEDRIN PM TRIPLE ACTION CAPLETS 
    acetaminophen, aspirin (nsaid) and diphenhydramine citrate tablet, coated
    Product Information
    Item Code (Source)NDC:0067-2056
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Product Characteristics
    ColorBLUE (light blue) Scoreno score
    ShapeRECTANGLESize17mm
    FlavorImprint Code EXPM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-2056-241 in 1 CARTON
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/01/2017
    Part 2 of 2
    EXCEDRIN  TENSION HEADACHE
    acetaminophen, caffeine tablet, film coated
    Product Information
    Item Code (Source)NDC:0067-8139
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVAL ((Caplet)) Size17mm
    FlavorImprint Code ETH
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8139-021 in 1 CARTON
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/01/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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