EXTRA STRENGTH PAIN RELIEVER

Manufacturer
Mechanical Servants LLC
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:42:39

Label at a glance#

ProductEXTRA STRENGTH PAIN RELIEVER
Active ingredientACETAMINOPHEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Analgesic, Antipyretic (fever reducer)

INDICATIONS & USAGE SECTION

Uses: temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor arthritis pain

Temporarily reduces fever

WARNINGS SECTION

Warnings:

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 (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • you have 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 product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

When using this product do not exceed recommended dose.

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 or fever persists or 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: consult a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: corn starch, hydroxypropyl methylcelluslose*, maltodextrin*, polyethylen glycol*, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

*contains one or more of these ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength

PAIN RELIEVER

Acetaminophen

Pain Reliever / Fever Reducer

COMPARE TO THE ACTIVE INGREDIENTS IN

TYLENOL ® EXTRA STRENGTH*

6 TABLETS

ES Pain RelieverES Pain Reliever

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN4
198440acetaminophen 500 MG Oral TabletSCD4
198440APAP 500 MG Oral TabletSY4

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-7626-6EXTRA STRENGTH PAIN RELIEVER3 in 1 PACKETTABLET34
29485-7626-6EXTRA STRENGTH PAIN RELIEVER2 in 1 POUCHTABLET24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-7626EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [MECHANICAL SERVANTS LLC]4Legacy NDC, 2 package rows20211008_c08f5ac3-b2cf-44e8-9e38-259addf61abd.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29485-762629485-7626-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b4505356-edfd-3a43-e053-2995a90aa41cc08f5ac3-b2cf-44e8-9e38-259addf61abd2021-10-06WarningsExact identifier
spl id: b4505356-edfd-3a43-e053-2995a90aa41c
spl set id: c08f5ac3-b2cf-44e8-9e38-259addf61abd

Reported adverse events (FAERS/openFDA)#

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