FDA.reportPublic FDA data

Extra Strength Pain Reliever

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-06-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:13:55

Label at a glance#

ProductExtra Strength Pain Reliever
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Storage and handling

do not use if inner pouch or carton is open or damaged store at room temperature 59-86˚F (15-30˚C) see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours.

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

SPL UNCLASSIFIED SECTION

: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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
    adults and children 12 years and over
    • take 2 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 yearsask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • do not use if inner pouch or carton is open or damaged
  • store at room temperature 59-86˚F (15-30˚C)
  • see bottom panel for lot number and expiration date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, maltodextrin 1 , microcrystalline cellulose 1 , polyethylene glycol, povidone 1 , pregelatinized starch 1 , sodium starch glycolate 1 , stearic acid, titanium dioxide 1

1 may contain

Questions or Comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-351-2000 (M-F 8:00 AM-4:30 PM CST)

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by JOHNSON & JOHNSON, INC., McNeil Consumer Healthcare Division,

distributor of Tylenol® Extra Strength.

Manufactured for:

Lil' Drug Store products, Inc.

9300 Earhart Lane SW

Cedar Rapids, IA 52404

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN

Tylenol® Extra Strength*

Extra Strength

Pain Reliever

Acetaminophen 500mg

Pain Reliever/Fever Reducer

actual size [pill image]

2 TABLETS PER POUCH

ES Pain RelieverES Pain Reliever

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN5
198440acetaminophen 500 MG Oral TabletSCD5
198440APAP 500 MG Oral TabletSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-9281-2Extra Strength Pain Reliever25 in 1 BOXTABLET255
29485-9281-2Extra Strength Pain Reliever2 in 1 POUCHTABLET25
29485-9281-3Extra Strength Pain Reliever2 in 1 POUCHTABLET25
29485-9281-3Extra Strength Pain Reliever30 in 1 BOXTABLET305
29485-9281-4Extra Strength Pain Reliever2 in 1 POUCHTABLET25
29485-9281-4Extra Strength Pain Reliever50 in 1 BOXTABLET505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-9281EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN 500 MG) TABLET [LIL' DRUG STORE PRODUCTS, INC.]5Current NDC, Legacy NDC, 6 package rows20240621_ee8e0e79-4da4-101f-e053-2a95a90a30a4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29485-928129485-9281-3, 29485-9281-2, 29485-9281-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
STEARIC ACID4ELV7Z65APIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Pain RelieverACETAMINOPHEN 500 MGLil' Drug Store Products, Inc.ee8e0e79-4da4-101f-e053-2a95a90a30a42024-06-19WarningsExact identifier
ndc (package): 29485-9281-3
ndc (package): 29485-9281-4
ndc (package): 29485-9281-2
ndc (product): 29485-9281
ndc11 (package): 29485928102
ndc11 (package): 29485928103
ndc11 (package): 29485928104
spl id: 1b444ae7-1662-e4ba-e063-6394a90a1f4e
spl set id: ee8e0e79-4da4-101f-e053-2a95a90a30a4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.