DailyMed - LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH (2024)

Table of Contents
View Package Photos Drug Label Info Safety Related Resources More Info For This Drug Drug Label Information Liver warning Allergy Alert Do not use Stop use and ask a doctor if Overdose warning Find additional resources Safety Related Resources More Info on this Drug View Labeling Archives for this drug LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet RxNorm LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet Get Label RSS Feed for this Drug LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet NDC Codes LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet
  • Label RSS
  • NDC Code(s): 66715-6817-4, 66715-6827-4, 66715-6837-4
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 22, 2021

If you are a consumer or patient please visit this version.

  • Download DRUG LABEL INFO: PDF XML
  • Official Label (Printer Friendly)

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses
    • temporarily relieves minor aches and pains due to:
      • headache
      • the common cold
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever
  • 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.

    See Also
    acetaminophen oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMDTCL 341 Pill – Uses, Dosage, Side Effects & FAQs - HealthpluscityExtra Pain Relief Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMDtcl 340 ROUND WHITE Images

    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.
    • 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.

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    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

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 and over
      • take 2 caplets every 6 hours while symptoms last
      • do not take more than 6 caplets in 24 hours
      • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: do not use
  • Other information
    • store between 68-77°F (20-25°C)
  • Inactive ingredients

    corn starch, croscarmellose sodium 1, hypromellose 1, lactose monohydrate 1, magnesium stearate 1, maltodextrin 1, medium-chain triglycerides 1, mineral oil 1, polydextrose 1, polyethylene glycol 1, polyvinyl alcohol 1, povidone, purified water 1, sodium starch glycolate 1, stearic acid 1, talc 1, titanium dioxide

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

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

  • SPL UNCLASSIFIED SECTION

    Product distributed by:
    Lil' Drug Store Products, Inc.
    9300 Earhart Lane SW
    Cedar Rapids, IA 52404

  • PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle Carton - NDC 66715-6817-4

    QUALITY
    GUARANTEED

    Compare to the
    Active Ingredient in
    Tylenol® Extra Strength**

    Extra Strength

    Pain Reliever

    Acetaminophen

    Pain Reliever/Fever Reducer, 500 mg

    ACTUAL SIZE

    24
    Caplets

    Lil'
    Drug Store ®

    DailyMed - LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH (4)

  • PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle Carton - NDC 66715-6827-4

    QUALITY
    GUARANTEED

    Compare to the
    Active Ingredient in
    Tylenol® Extra Strength**

    Extra Strength

    Pain Reliever

    Acetaminophen

    Pain Reliever/Fever Reducer, 500 mg

    ACTUAL SIZE

    24
    Caplets

    Lil'
    Drug Store ®

    DailyMed - LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH (5)

  • PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle Carton - NDC 66715-6837-4

    QUALITY
    GUARANTEED

    Compare to the
    Active Ingredient in
    Tylenol® Extra Strength**

    Extra Strength

    Pain Reliever

    Acetaminophen

    Pain Reliever/Fever Reducer, 500 mg

    ACTUAL SIZE

    24
    Caplets

    Lil'
    Drug Store ®

    DailyMed - LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH (6)

  • INGREDIENTS AND APPEARANCE
    LIL DRUG STORE PAIN RELIEVEREXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6817
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
    MAGNESIUM STEARATE (UNII: 70097M6I30)
    MALTODEXTRIN (UNII: 7CVR7L4A2D)
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
    MINERAL OIL (UNII: T5L8T28FGP)
    POLYDEXTROSE (UNII: VH2XOU12IE)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
    WATER (UNII: 059QF0KO0R)
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
    STEARIC ACID (UNII: 4ELV7Z65AP)
    TALC (UNII: 7SEV7J4R1U)
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code P500
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6817-41 in 1 CARTON04/15/201908/12/2024
    124 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 finalpart34301/10/201508/12/2024
    LIL DRUG STORE PAIN RELIEVEREXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6827
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
    MAGNESIUM STEARATE (UNII: 70097M6I30)
    MALTODEXTRIN (UNII: 7CVR7L4A2D)
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
    MINERAL OIL (UNII: T5L8T28FGP)
    POLYDEXTROSE (UNII: VH2XOU12IE)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
    WATER (UNII: 059QF0KO0R)
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
    STEARIC ACID (UNII: 4ELV7Z65AP)
    TALC (UNII: 7SEV7J4R1U)
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code AV;0821
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6827-41 in 1 CARTON04/15/201908/12/2024
    124 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 finalpart34301/10/201508/12/2024
    LIL DRUG STORE PAIN RELIEVEREXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6837
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
    MAGNESIUM STEARATE (UNII: 70097M6I30)
    MALTODEXTRIN (UNII: 7CVR7L4A2D)
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
    MINERAL OIL (UNII: T5L8T28FGP)
    POLYDEXTROSE (UNII: VH2XOU12IE)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
    WATER (UNII: 059QF0KO0R)
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
    STEARIC ACID (UNII: 4ELV7Z65AP)
    TALC (UNII: 7SEV7J4R1U)
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TCL;341
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6837-41 in 1 CARTON04/15/201908/12/2024
    124 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 finalpart34301/10/201508/12/2024

    Labeler -Lil' Drug Store Products, Inc.(093103646)

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Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!

View Labeling Archives for this drug

LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

Number of versions: 3

Published Date (What is this?) Version Files
Dec 23, 2021 3 (current) download
Jun 23, 2020 2 download
Apr 2, 2019 1 download

RxNorm

LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

RxCUI RxNorm NAME RxTTY
1 198440 acetaminophen 500 MG Oral Tablet PSN
2 198440 acetaminophen 500 MG Oral Tablet SCD
3 198440 APAP 500 MG Oral Tablet SY

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LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

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NDC Codes

LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 66715-6817-4
2 66715-6827-4
3 66715-6837-4
DailyMed - LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH (2024)
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