Pain Reliever 2

Manufacturer
Redicare LLC
Effective date
2021-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:13

Label at a glance#

ProductPain Reliever 2
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure8 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 6 hours as needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period Children under 12 years: Ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg

Purpose

OTC - PURPOSE SECTION

pain reliever/fever reducer, adjuvant

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION


Reye’s syndrome: Children and teenagers should not use this medicine for chickenpox 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 AND PRECAUTIONS 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 AND PRECAUTIONS 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 an 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 ■ with large amounts of caffeinated products

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

■ asthma, liver, kidney, high blood pressure or heart disease ■ stomach problems (such as heartburn, upset or painful stomach) ■ gastric ulcers ■ bleeding problems ■ taking a diuretic ■ or if the stomach bleeding warning applies to you

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 ■ with other drugs or conditions

When using this product

OTC - WHEN USING SECTION

do not exceed the recommended dose.

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 worsens ■ new symptoms occur ■ allergic reaction, 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 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 6 hours as needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period

Children under 12 years: Ask a doctor

Other Information:

STORAGE AND HANDLING SECTION

■ Tamper Evident. Do not use if a 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

hypromellose*, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide*

*contains one or more of these ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN2
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD2
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY2

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
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71105-174-682023-01-30C16284748780-1f386c649-bfe6-0266-e053-dadaa90a7c1aAdvanced Pain Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71105-174-02Pain Reliever 22 in 1 PACKAGETABLET22
71105-174-68Pain Reliever 250 in 1 BOXTABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71105-174PAIN RELIEVER 2 (PAIN RELIEVER) TABLET [REDICARE LLC]2Legacy NDC, 2 package rows20210703_9b43f780-b832-6234-e053-2a95a90aa681.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71105-17471105-174-02, 71105-174-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
c62a329f-508f-78ad-e053-2a95a90a9b2a9b43f780-b832-6234-e053-2a95a90aa6812021-07-02WarningsExact identifier
spl id: c62a329f-508f-78ad-e053-2a95a90a9b2a
spl set id: 9b43f780-b832-6234-e053-2a95a90aa681

Reported adverse events (FAERS/openFDA)#

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