EXTRA STRENGTH PAIN RELIEF

Manufacturer
DIRECT RX
Effective date
2021-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:57:41

Label at a glance#

ProductEXTRA STRENGTH PAIN RELIEF
Active ingredientACETAMINOPHEN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

OTC - WHEN USING SECTION

temporarily relieves minor aches and pains
temporarily reduces fever

WARNINGS SECTION

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 tablets 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

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.

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 symptom 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.

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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children.

OTC - WHEN USING SECTION

do not take more than directed
adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
children under 12 years: do not use

OTHER SAFETY INFORMATION

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
store at 20⁰C-25⁰C (68⁰F-77⁰F)
for institutional use only

INACTIVE INGREDIENT SECTION

povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

271271

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-271-502021-01-07C16284748780-19d75b9d0-9625-f424-e053-dadaa90a57ceACETAMINOPHEN
61919-271-502020-01-31C16284748780-19d75b9d0-9625-f424-e053-dadaa90a57ceACETAMINOPHEN

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-271-50EA - Each61919-2718de7b20a-fe91-4458-b745-778dfca3090e12019-09-05
61919-271-60EA - Each61919-27128f6a524-c41b-4931-ac82-7348ce3eb73e12019-09-05
61919-271-71EA - Each61919-2716d473524-789f-4627-8184-efca2cccd24e12019-09-05
57896-201-01EA - Each57896-20182dbdfae-7cce-45e7-bf0c-c214686bb89612012-07-24
57896-201-05EA - Each57896-2015d0770cd-70c2-4757-896d-62e868f751c012022-06-06
57896-201-10EA - Each57896-201aa5f4c60-e670-45f2-861b-c2ad8e686e2a12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-27161919-271-50
57896-201

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp7570aaa2-3238-4cd3-b788-915caa970dba2025-12-04WarningsExact identifier
ndc (product): 57896-201
0749f285-e09c-0697-e063-6294a90a2e2a676061c0-af5e-2be9-e053-2991aa0a24452023-10-09WarningsExact identifier
spl set id: 676061c0-af5e-2be9-e053-2991aa0a2445

Reported adverse events (FAERS/openFDA)#

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