Label: EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE- acetaminophen, aspirin (nsaid), caffeine, and diphenhydramine citrate

  • NDC Code(s): 0067-2056-24, 0067-8139-02, 0067-8147-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 10, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Excedrin PM Headache
  • Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID*)

    Diphenhydramine citrate 38 mg

    *nonsteroidal anti-inflammatory drug

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  • Purposes

    Pain Reliever

    Pain Reliever

    Nighttime sleep-aid

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  • Uses

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

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  • 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
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  • 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.
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  • 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

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  • Questions or comments?

    1-800-452-0051

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  • Excedrin Tension Headache
  • Active Ingredients (in each caplet)

    Acetaminophen 500 mg

    Caffeine 65 mg

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  • Purposes

    Pain reliever

    Pain reliever aid

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  • Uses

    temporarily relieves minor aches and pain due to:
    o
    headache

    muscular aches

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  • 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.

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  • 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

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  • 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.

    Close
  • 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

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  • Questions or comments?

    1-800-452-0051

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  • 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
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  • 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
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  • INGREDIENTS AND APPEARANCE
    EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN TENSION HEADACHE 
    acetaminophen, aspirin (nsaid), caffeine, and diphenhydramine citrate kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8147
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-8147-01 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 06/01/2017
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE 24 
    Part 2 1 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 Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color BLUE (light blue) Score no score
    Shape RECTANGLE Size 17mm
    Flavor Imprint Code EXPM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-2056-24 1 in 1 CARTON
    1 24 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/01/2017
    Part 2 of 2
    EXCEDRIN  TENSION HEADACHE
    acetaminophen, caffeine tablet, film coated
    Product Information
    Item Code (Source) NDC:0067-8139
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color RED Score no score
    Shape OVAL ((Caplet)) Size 17mm
    Flavor Imprint Code ETH
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-8139-02 1 in 1 CARTON
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/01/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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