- Label RSS
Drug Label Info
Safety
- Report Adverse Events
- FDA Safety Recalls
- Presence in Breast Milk
Related Resources
- Medline Plus
- Clinical Trials
- PubMed
- All Citations
- Adverse Effects
- Therapeutic Use
- Pharmacology
- Clinical Trials
- Biochemical Data Summary
More Info For This Drug
- View Labeling Archives
- RxNorm
- Get Label RSS Feed
- View NDC Code(s)NEW!
- 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)
View All Sections
- 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
- temporarily relieves minor aches and pains due to:
- 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.
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.
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
GUARANTEEDCompare to the
Active Ingredient in
Tylenol® Extra Strength**Extra Strength
Pain Reliever
Acetaminophen
Pain Reliever/Fever Reducer, 500 mg
ACTUAL SIZE
24
CapletsLil'
Drug Store ® - PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle Carton - NDC 66715-6827-4
QUALITY
GUARANTEEDCompare to the
Active Ingredient in
Tylenol® Extra Strength**Extra Strength
Pain Reliever
Acetaminophen
Pain Reliever/Fever Reducer, 500 mg
ACTUAL SIZE
24
CapletsLil'
Drug Store ® - PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle Carton - NDC 66715-6837-4
QUALITY
GUARANTEEDCompare to the
Active Ingredient in
Tylenol® Extra Strength**Extra Strength
Pain Reliever
Acetaminophen
Pain Reliever/Fever Reducer, 500 mg
ACTUAL SIZE
24
CapletsLil'
Drug Store ® - INGREDIENTS AND APPEARANCE
LIL DRUG STORE PAIN RELIEVEREXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6817 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500mg Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code P500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6817-4 1 in 1 CARTON 04/15/2019 08/12/2024 1 24 in 1 BOTTLE, PLASTIC; 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 01/10/2015 08/12/2024 LIL DRUG STORE PAIN RELIEVEREXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6827 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500mg Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code AV;0821 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6827-4 1 in 1 CARTON 04/15/2019 08/12/2024 1 24 in 1 BOTTLE, PLASTIC; 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 01/10/2015 08/12/2024 LIL DRUG STORE PAIN RELIEVEREXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6837 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500mg Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code TCL;341 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6837-4 1 in 1 CARTON 04/15/2019 08/12/2024 1 24 in 1 BOTTLE, PLASTIC; 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 01/10/2015 08/12/2024 Labeler -Lil' Drug Store Products, Inc.(093103646)
View All Sections
Find additional resources
(also available in the left menu)
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 |
Get Label RSS Feed for this Drug
LIL DRUG STORE PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet
To receive this label RSS feed
Copy the URL below and paste it into your RSS Reader application.
https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=4b397bdb-efe6-4088-8e66-c77eb3bb80f2
To receive all DailyMed Updates for the last seven days
Copy the URL below and paste it into your RSS Reader application.
https://dailymed.nlm.nih.gov/dailymed/rss.cfm
What will I get with the DailyMed RSS feed?
DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.
How to discontinue the RSS feed
If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.
Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?
Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
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 |