Tension Headache Relief

Manufacturer
NUVICARE LLC
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:27:29

Label at a glance#

ProductTension Headache Relief
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure14 sections

Indications and uses

temporarily relieves minor aches and pains due to: •headache •muscular aches

Dosage and administration

Do not use more than directed adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours chlidren under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients  (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg
Caffeine 65 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen 500mg................................Pain reliever
Caffeine 65mg............................................Pain reliever aid

Uses:

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

•headache
•muscular aches

Warnings:

WARNINGS SECTION

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.

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

•no more than 6 caplets 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

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 while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

DO NOT USE:

•if you have ever had an allergic reaction to acetaminophen
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

•you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

•taking the blood thinning drug warfarin

Stop use and ask doctor if 

OTC - STOP USE SECTION

■any new symptoms occur

■painful area is red or swollen

■pain gets worse or lasts for more than 10 days

■fever gets worse or lasts for more than 3 days. 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 (1-800-222-1222) right away. Quick 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

  • Do not use more than directed
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
  • chlidren under 12 years: ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

•store at 20°-25°C (68°-77°F)

•close cap tightly after use
•read all product information before using.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 1 (718) 337-8733 or visit support@nuvicare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0216-01 NC-Tension Headache Relief-100ct.jpgPL0216-01 NC-Tension Headache Relief-100ct.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN3
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD3
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130384324000152GTIN-13: 0384324000152
EAN-13: 0384324000152
GTIN-12: 384324000152
UPC-A: 384324000152
GTIN storage (14 digits): 00384324000152
PL0216-01 NC-Tension Headache Relief-100ct.jpg

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
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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7dfac40f-a405-cd2e-7c06-3059ec0e1092Product 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-002-01Tension Headache Relief100 in 1 BOTTLETABLET1003

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84324-00284324-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
Tension Headache ReliefACETAMINOPHEN, CAFFEINENUVICARE LLCea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e2025-12-19WarningsExact identifier
ndc (package): 84324-002-01
ndc (product): 84324-002
ndc11 (package): 84324000201
spl id: 407cbaec-b2d2-418c-b643-9b9bb883b2c7
spl set id: ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e

Reported adverse events (FAERS/openFDA)#

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