Extra Strength Pain Reliever

Manufacturer
Redicare LLC
Effective date
2021-07-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:12

Label at a glance#

ProductExtra Strength Pain Reliever
Active ingredientASPIRIN, ACETAMINOPHEN, SALICYLAMIDE, CAFFEINE
Label structure15 sections

Indications and uses

temporarily relieves minor aches and pains associated with ■ headaches ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache

Dosage and administration

Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, with a full glass of water. Do not exceed 6 tablets in any 24 hour period Children under 12 years: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 110 mg .....................................................................................pain reliever/fever reducer

Aspirin 162 mg .....................................................................................................pain reliever/fever reducer

Caffeine 32.4 mg...............................................................................................................................adjuvant

Salicylamide 152 mg............................................................................................pain reliever/fever reducer

Uses:

OTC - PURPOSE SECTION

temporarily relieves minor aches and pains associated with ■ headaches ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache

Warnings: Reye’s syndrome:

WARNINGS SECTION

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.

Liver Warning:

WARNINGS SECTION

This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Warning:

WARNINGS SECTION

This product contains a non-steroidal anti-inflammatory drug (NSAIDs), which may cause stomach bleeding. The chance is higher if you ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ are age 60 or older ■ have 3 or more alcoholic drinks every day while using this product ■ take with other drugs containing a NSAID ■ you take more or for a longer time than directed.

Do not use:

OTC - DO NOT USE SECTION

■ if you are allergic to aspirin ■ with any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor ■ with any other product containing acetaminophen

Ask doctor before using if you have:

OTC - ASK DOCTOR SECTION

■ asthma ■ stomach problems (such as heartburn, upset stomach or stomach pain) ■ gastric ulcers ■ bleeding problems

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking a prescription drug for ■ anticoagulation (thinning of blood) ■ diabetes ■ gout ■ arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present

If pregnant or breast-feeding a baby,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In a 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.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, with a full glass of water. Do not exceed 6 tablets in any 24 hour period
Children under 12 years: Ask a doctor

Other Information:

INDICATIONS & USAGE SECTION

■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch and stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359221acetaminophen 110 MG / aspirin 162 MG / salicylamide 152 MG / caffeine 32.4 MG Oral TabletPSN3
359221acetaminophen 110 MG / aspirin 162 MG / caffeine 32.4 MG / salicylamide 152 MG Oral TabletSCD3
359221APAP 110 MG / ASA 162 MG / Caffeine 32.4 MG / salicylamide 152 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71105-242-682023-01-30C16284748780-1f386c64a-0522-0266-e053-dadaa90a7c1aPain Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71105-242-68Extra Strength Pain Reliever100 in 1 CARTONTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71105-242EXTRA STRENGTH PAIN RELIEVER TABLET [REDICARE LLC]3Legacy NDC, 1 package rows20210703_47df5786-b918-3a3e-e054-00144ff88e88.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
71105-24271105-242-68

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
c62a10de-a02c-308c-e053-2995a90a8f5947df5786-b918-3a3e-e054-00144ff88e882021-07-02WarningsExact identifier
spl id: c62a10de-a02c-308c-e053-2995a90a8f59
spl set id: 47df5786-b918-3a3e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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