Label: HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet, film coated

  • NDC Code(s): 50844-159-12, 50844-159-16
  • Packager: L.N.K. International, Inc.
  • 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 19, 2019

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  • Active ingredients (in each tablet)

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • arthritis
      • muscular aches
      • a cold
      • toothache
      • premenstrual and menstrual cramps
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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: Aspirin may cause a severe allergic reaction, which may include:

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

    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 4000 mg of acetaminophen in 24 hours
    • 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

    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 heartbeat.

    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    • you have liver disease
    • you have asthma
    • you are taking a diuretic
    • 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

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug or are under a doctor's care for any serious condition

    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:
      • vomit blood
      • feel faint
      • have bloody or black stools
      • have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • 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 3 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 (1-800-222-1222) right away. Prompt 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 take more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over
      • take 2 tablets every 6 hours
      • do not take more than 8 tablets in 24 hours
    • children under 12 years: ask a doctor
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • use by expiration date on package
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  • Inactive ingredients

    corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

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  • Principal Display Panel

    QUALITY
          
    PLUS

    NDC 50844-159-16

    †Compare to the active ingredients
    in Excedrin® Extra Strength

    EXTRA STRENGTH
    HEADACHE RELIEF
    Acetaminophen, Aspirin (NSAID)
    and Caffeine

    PAIN RELIEVER, PAIN RELIEVER AID

    RELIEVES HEADACHES, ARTHRITIS, AND MUSCULAR ACHES

    1000 Tablets

    ACTUAL SIZE

    This product is not manufactured or distributed by
    Novartis AG, owner of the registered trademark
    Excedrin® Extra Strength.
    50844       REV0418A15916

    Distributed by:
    LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788
    USA

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Quality Plus 44-159

    Quality Plus 44-159

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  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF  EXTRA STRENGTH
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-159
    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
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;159
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50844-159-12 1 in 1 CARTON 11/17/1992
    1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:50844-159-16 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/17/1992
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 11/17/1992
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(50844-159)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(50844-159)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(50844-159)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(50844-159)
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