Lil' Drug Store® Headache Relief Extra Strength

Lil' Drug Store® Headache Relief Extra Strength

Drug Labeling and Warnings

Drug Details

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LIL DRUG STORE HEADACHE RELIEF  EXTRA STRENGTH- acetaminophen, aspirin, and caffeine tablet 
Lil' Drug Store Products, Inc.

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.

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Lil' Drug Store® Headache Relief
Extra Strength

Drug Facts

Active ingredients (in each caplet)Purposes
  • * nonsteroidal anti-inflammatory drug
  • Acetaminophen 250 mgPain reliever
    Aspirin 250 mg (NSAID)*Pain reliever
    Caffeine 65 mgPain reliever aid

    Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • a cold
      • arthritis
      • muscular aches
      • toothache
      • premenstrual and menstrual cramps

    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 8 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

    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.

    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

    Ask a doctor or pharmacist before use if you are taking

    • a prescription drug for diabetes, gout, or arthritis
    • 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
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better.
    • ringing in the ears or loss of hearing occurs
    • 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
    • any new symptoms appear

    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 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
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours
    • children under 12 years: do not use unless directed by a doctor

    Other information

    • store between 20°-25°C (68°-77°F)

    Inactive ingredients

    carnauba wax1, colloidal silicon dioxide, corn starch, hypromellose, microcrystalline cellulose, mineral oil1, polyethylene glycol1, povidone, sodium starch glycolate1, stearic acid, talc1, titanium dioxide1


  • 1 contains one or more of these ingredients
  • Questions or comments?

    Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

    Product distributed by:
    Lil' Drug Store Products, Inc.
    1201 Continental Place NE
    Cedar Rapids, IA 52402

    PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton - NDC: 66715-6822-4

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active
    Ingredients in Excedrin®
    Extra Strength

    Extra Strength

    Headache

    Acetaminophen,
    Aspirin (NSAID) and Caffeine
    Pain Reliever/Pain Reliever Aid

    ACTUAL SIZE

    50
    Caplets

    Lil'
    Drug Store
    ®

    PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton - NDC: <a href=66715-6822-4" src="https://fda.report/DailyMed/5041ed14-6115-4a51-a279-08d6800732a4/headache-01.jpg" id="309089"/>

    PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton - NDC: 66715-5822-4

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active
    Ingredients in Excedrin®
    Extra Strength

    Extra Strength

    Headache

    Acetaminophen,
    Aspirin (NSAID) and Caffeine
    Pain Reliever/Pain Reliever Aid

    ACTUAL SIZE

    50
    Caplets

    Lil'
    Drug Store
    ®

    PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton - NDC: <a href=66715-5822-4" src="https://fda.report/DailyMed/5041ed14-6115-4a51-a279-08d6800732a4/headache-02.jpg" id="309089"/>
    LIL DRUG STORE HEADACHE RELIEF   EXTRA STRENGTH
    acetaminophen, aspirin, and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66715-6822
    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
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine65 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Polydextrose (UNII: VH2XOU12IE)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    C10-18 Triglycerides (UNII: 43AGM4PHPI)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code TCL370
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 66715-6822-41 in 1 CARTON11/27/2017
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34311/27/2017
    LIL DRUG STORE HEADACHE RELIEF   EXTRA STRENGTH
    acetaminophen, aspirin, and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66715-5822
    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
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine65 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Polydextrose (UNII: VH2XOU12IE)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    C10-18 Triglycerides (UNII: 43AGM4PHPI)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 2793
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 66715-5822-41 in 1 CARTON11/27/2017
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34311/27/2017
    Labeler - Lil' Drug Store Products, Inc. (093103646)

    Revised: 2/2018
     
    Lil' Drug Store Products, Inc.


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