FDA.reportPublic FDA data

Pain Reliever

Manufacturer
Walgreens
Effective date
2023-10-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:56:33

Label at a glance#

ProductPain Reliever Extra Strength
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) do not take more then 4 doses in any 24 hours period measure only with dosing cup provided. Do not use any other dosing device mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 6 hours while symptoms last do not take more than 10 days unless directed by a doctor children under 12 years: do not use 

Storage and handling

each 15 mL contains :sodium 6 mg  store between 20-25ºC (68-77ºF) do not refrigerate protect from light

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL)

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:  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 ever 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

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 or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for 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)
  • do not take more then 4 doses in any 24 hours period
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL every 6 hours while symptoms last
    • do not take more than 10 days unless directed by a doctor
  • children under 12 years: do not use 

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains:sodium 6 mg 
  • store between 20-25ºC (68-77ºF) do not refrigerate
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red 33, FD&C red 40, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Campare to the active ingredient in Tylenol® Extra Strength††

ADULT

Pain Reliever

ACETAMINOPHEN 500 mg per 15 mL /

PAIN RELIEVER / FEVER REDUCER

Extra Strength  12 Years& Older

CHERRY FLAVOR

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

††This product is not manufactured or distributed by Johnson & Johnson, owner of the registered Trademark Tylenol®.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS Adult Pain Reliever
WALGREENS Adult Pain Reliever

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN6
307684acetaminophen 33.3 MG/ML Oral SolutionSCD6
307684APAP 1000 MG per 30 ML Oral SolutionSY6
307684APAP 167 MG per 5 ML Oral SolutionSY6
307684APAP 33.3 MG/ML Oral SolutionSY6
307684APAP 500 MG per 15 ML Oral SolutionSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0278-082023-10-09C16284748780-1f386c64a-0362-0266-e053-dadaa90a7c1aDrug Facts
0363-0278-082023-01-30C16284748780-1f386c64a-0362-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0278-08Pain RelieverExtra Strength237 mL in 1 BOTTLE, PLASTICLIQUID2376

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0278PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) LIQUID [WALGREENS]6Current NDC, Legacy NDC, 1 package rows20231010_b4b06d32-6a09-4c43-980b-377b617ba739.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0278-08ML - Milliliter0363-0278fc10248a-4b3d-40b1-8d10-63785190ccfa12020-05-08

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
0363-02780363-0278-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT

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
Pain Reliever Extra StrengthACETAMINOPHENWalgreensb4b06d32-6a09-4c43-980b-377b617ba7392023-10-09WarningsExact identifier
ndc (package): 0363-0278-08
ndc (product): 0363-0278
ndc11 (package): 00363027808
spl id: 9596606a-d83c-44a9-9cbf-89b27ed87e30
spl set id: b4b06d32-6a09-4c43-980b-377b617ba739

Reported adverse events (FAERS/openFDA)#

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