EXTRA PAIN RELIEF

Manufacturer
Apace Packaging, LLC | Time Cap Laboratories, Inc.
Effective date
2018-11-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:47:25

Label at a glance#

ProductEXTRA PAIN RELIEF
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 sections

Indications and uses

TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACETAMINOPHEN 250 MG

ASPIRIN 250 MG (nsaid*)

CAFFEINE 65 MG
* NONSTEROIDAL ANIT-INFLAMMATORY DRUG

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Povidone, Pregelatinized Starch, Sodium Starch Gylolate, Stearic Acid, Titanium Dioxide

OTC - PURPOSE SECTION

PAIN RELIEVER - PAIN RELIEVER AID

DIRECTIOINS

DOSAGE & ADMINISTRATION SECTION

DO NOT USE MORE THAN DIRECTED - DRINK A FULL GLASS OF WATER WITH EACH DOSE - ADULTS AND CHILDREN 12 YEARS AND OVER TAKE 2 TABLETS EVERY 6 HOURS, NOT MORE THAN 8 TABLETS IN 24 HOURS .

USES

INDICATIONS & USAGE SECTION

TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to acetaminophe, aspirin or any other pain reliever/fever reducer; with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

WARNINGS

WARNINGS SECTION

REYE'S SYNDROME:

Children and teenages who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an eary sign of Reye's syndrome, a rare but serious illnes.

ALLERY ALERT

Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (sheezing)

shock

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 usng this product

STOMACH BLEEDING WARNING:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older;

have had stomach ulcers or bleeding problems

take a blood thinning (anticogulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,naproxen, or others)

take more or for a longer time than directed

CAFFEINE WARNING:

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine containing medications, foods or beverages which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 sighs or symptoms

PREGNANCY SECTION

If Pregnant or breast-feeding ask a helth professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor becausde it may cause prombles inthe unborn child or complications during delivery.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-053-15
EXTRA PAIN RELIEF
Acetaminophen, Aspirin (NSAID) and Caffeine
EXTRA STREGTH
50 Tablets (5 X 10) Unit Dose

5026805315

NDC 50268-053-15
EXTRA PAIN RELIEF
Acetaminophen, Aspirin (NSAID) and Caffeine
EXTRA STREGTH
50 Tablets (5 X 10) Unit Dose

5026805315

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15338-703-052020-01-31C16284748780-19d75b9d0-0c8e-f424-e053-dadaa90a57ceAcetaminophen, Aspirin (NSAID) and Caffeine (Product contract packaged by Apace Packaging, LLC)

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15338-70315338-703-11, 15338-703-05
49483-370

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 PAIN RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINETIME CAP LABS59482917-f80b-4bed-9218-068b35366eb32025-07-11WarningsExact identifier
ndc (product): 49483-370
7a9269a4-c0bf-9a93-e053-2991aa0a3c487a92a39a-5c6e-483b-e053-2991aa0abc2a2018-11-13WarningsExact identifier
spl id: 7a9269a4-c0bf-9a93-e053-2991aa0a3c48
spl set id: 7a92a39a-5c6e-483b-e053-2991aa0abc2a

Reported adverse events (FAERS/openFDA)#

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